{"id":50392,"date":"2023-09-30T11:12:54","date_gmt":"2023-09-30T11:12:54","guid":{"rendered":"https:\/\/biomedpharmajournal.org\/?p=50392"},"modified":"2023-10-07T09:14:26","modified_gmt":"2023-10-07T09:14:26","slug":"impact-on-psychomotor-functions-by-sedative-agents-used-during-daycare-surgeries-a-randomized-controlled-double-blinded-study-of-dexmedetomidine-versus-midazolam-fentanyl","status":"publish","type":"post","link":"https:\/\/biomedpharmajournal.org\/staging\/vol16no3\/impact-on-psychomotor-functions-by-sedative-agents-used-during-daycare-surgeries-a-randomized-controlled-double-blinded-study-of-dexmedetomidine-versus-midazolam-fentanyl\/","title":{"rendered":"Impact on Psychomotor Functions by Sedative Agents Used During Daycare Surgeries: A Randomized Controlled Double-Blinded Study of Dexmedetomidine Versus Midazolam-Fentanyl"},"content":{"rendered":"\n

Introduction<\/strong><\/p>\n\n\n\n

Sedative\nagents are routinely used in all surgeries. They help reduce stress, anxiety and\nminimize their discomfort. An ideal sedation agent should have rapid induction,\nshould be able to provide stable operating conditions with minimal side effects\nand rapid post-op recovery.1<\/sup>Patient-de\ufb01ned recovery mainly emphasize\non physiological and physical function parameters, but actually recovery also\nincludes cognitive and psychomotor domains2<\/sup>; which is often ignored\nin clinical practice.<\/p>\n\n\n\n

Postoperative\ncognitive dysfunction arises after surgery in form of memory impairment and\nimpaired performance on intellectual tasks. It also includes acute delirium. Baseline\ncognitive performance tests are used for diagnosis of POCD. Comparison of\npatient\u2019s cognitive performance to his own baseline values helps in assessing \u2018cognitive\nrecovery\u2019. POCD results from numerous contributory factors like age,\neducational level, and mental health of the patient. Risk of development of\nPOCD increases with advancing age in elderly patients. Minor surgical\nprocedures have low risk of developing POCD. With early recognition and\nmanagement of potential perioperative risk factors, POCD can be prevented. Delirium\nis an easily recognizable state whose symptoms may or may not be related to\nunderlying organic disease. Delirium is an independent predictor of many\nadverse outcomes such as morbidity and mortality.3<\/sup><\/p>\n\n\n\n

In\nthe current era, one of the commonly used drugs for sedation in surgeries under\nlocal anesthesia are midazolam, dexmedetomidine, and fentanyl. Fentanyl is a \u03bc-selective\nopioid agonist. It has rapid onset of action with duration of action of nearly\n30\u201360 minutes. Side effects may include respiratory depression, serotonin\nsyndrome, and hypotension.4<\/sup>Midazolam, a rapidly acting drug\nbelonging to benzodiazepines class of drug and its effects last for one to six\nhours. After repeated administration of midazolam, there may be delayed\nrecovery and increased incidence of side effects like excessive sleepiness and\npsychomotor impairment.5<\/sup>Dexmedetomidine is an \u03b12<\/sub> agonist having\nsedative, analgesic and sympatholytic properties. When dexmedetomidine is used\nfor sedation, patients remain easily arousable and have minimal effect on\nrespiration.6<\/sup><\/p>\n\n\n\n

In\nthis study, we tried to compare these drugs for their effects on post-operative\npsychomotor functions of the patients.<\/p>\n\n\n\n

Materials and Methods<\/strong><\/p>\n\n\n\n

This\nprospective, randomized, controlled, double\u2011blind study was conducted\nafter obtaining institutional ethics committee approval. 72 patients of either\nsex, aged between 18 and 60 years and falling into Grade I\/II of American\nSociety of Anesthesiologists (ASA) classification were included in the study. The sample size of 72 was calculated by\ntaking a difference of 8 minutes in post-operative recovery event from the\nprevious study \u2015Psychomotor recovery of dexmedetomidine compared with propofol\nafter sedation during spinal anesthesia\u2016 with the power of 80% and 5% \u03b1 error.<\/p>\n\n\n\n

Written\ninformed consent was obtained from all of them. Pregnant and lactating females,\npatients with known sensitivity to lignocaine and other study drugs were\nexcluded from the study. Using a computer-based randomization scheme, patients\nwere divided into two groups (36 patients each) i.e. Group D (dexmedetomidine)\nand Group MF (midazolam fentanyl). Group D patients received dexmedetomidine1\u00b5g\/kg\nIV over 10 minutes later followed by continuous infusion starting from 0.3\n\u00b5g\/kg\/hr. This was incremented by 0.1\u00b5g\/kg\/hr up to 0.7 \u00b5g\/kg\/hr till an adequate\nsedation score was achieved (Ramsay sedation scale =3). Group MF patients were\ngiven injection midazolam 0.03 mg\/kg IV and injection fentanyl 1\u00b5g\/kg IV bolus\nover 10 minutes followed by continuous midazolam infusion, 0.03 \u2013 0.07 mg\/kg\/hr\nand fentanyl, 0.5 \u2013 1.5 \u00b5g\/kg\/hr till adequate sedation score was achieved. Baseline\npsychomotor assessment by Mini mental state examination (MMSE)7<\/sup>&\nstroop color word interference test8<\/sup>, and delirium assessment by\nshort confusion assessment method (CAM)9<\/sup> and its severity was\nassessed by short CAM \u2013 severity score10<\/sup> at 30 min pre-op &\npost-operatively at 1, 2, 4 & 8 hours.<\/p>\n\n\n\n

MMSE\nwas used to examine psychomotor functions like registration (ability to repeat,\nretain & recall unrelated words), orientation (to time, place and person), attention,\nlanguage, recall and ability to follow simple commands. MMSE was scored\ndepending on the number of correctly answered questions and correctly completed\nactivities. Lower scores indicated poorer performance and greater cognitive\nimpairment. Maximum possible score was 30. On the basis of score obtained from\npatients, they were further divided into three sub groups. Score between 24-30\nwas indicative of no cognitive impairment while score between 18-23 indicated mild\ncognitive impairment and score between 0-17 corresponded to severe cognitive\nimpairment. <\/p>\n\n\n\n

In\nthe stroop color word interference test, a sheet on which colour names were\nprinted using four different colors, was given to the patient. No colour name\nwas printed in its matching colour. Eg the word \u2018blue\u2019 will not be printed in\nblue colour. Patients were given a total of 52 color names to read, either in\nHindi and English as per convenience of the patient and then  patients were asked to quickly name aloud, the\ncolor of the ink in which the word was printed, within 120s time period.\nInterference score was calculated by no. of items properly named in 120 seconds\n\u2013 no. of errors made. <\/p>\n\n\n\n

Presence\nor absence of delirium in the patient was assessed by short CAM. Short CAM\nhelped in assessing four clinical features of delirium. The first clinical\nfeature to be assessed was acute alteration in mental status with respect to\nbaseline (1a). 2nd feature of focus was inattention i.e. whether the patient\nwas easily distractible or unable to follow has been said\/ follow simple\ncommands (2a). It was also assessed whether this inattention behavior fluctuated\nduring the interview (2b). The 3rd feature was based upon disorganized thinking\npattern of the patient, like irrelevant conversation or illogical flow of ideas\n(3a) and whether this disorganized thinking pattern fluctuated during the\ninterview (3b). The 4th feature was based on altered level of consciousness\ni.e. whether the patient is alert, vigilant, lethargic, having stupor or in\ncoma (4a). It was also assessed whether this behavior fluctuated during the\ninterview (4b). The patients were considered to be in the state of delirium if\nthere was acute change in mental status of the patient (1a=1) or there was\nfluctuation in abnormal behavior of the patient in terms of inattention or\ndisorganized thinking or consciousness (2b or 3b or 4b = 1) and there was mild\nor marked difficulty in focusing attention (2a = 2,3 respectively) along with\neither mild to marked disorganized thinking (3a=2,3 respectively) or altered\nlevel of consciousness like vigilant, lethargic, stupor or coma (4a=2,3,4,5\nrespectively). Number of patients showing signs of delirium was calculated at\neach time of assessment. <\/p>\n\n\n\n

If\ndelirium was found to be present then severity of delirium was assessed by\nshort CAM\u2013severity score. Scores were then assigned to features according to\npresence & severity of symptoms. Absence of feature was assigned a score of\nzero (0), mild symptoms were assigned a score of one (1) and a score of two (2)\nwas assigned when features were present in marked form. Total scores of all the\nfeatures were added up to obtain the severity score of the patient. The score\nranged from 0-7. A higher total score indicated more severe delirium. Mean\ndelirium severity score of the patients was calculated by adding the delirium\nseverity scores of all patients and dividing it by total no. of patients.<\/p>\n\n\n\n

Statistical Analysis<\/strong><\/p>\n\n\n\n

All\nthe collected data were filled into a master-chart in a Microsoft Excel Sheet.\nMean \u00b1 S.D. was calculated for quantitative data. For intra group comparison,\npaired t-test and Repeated measure ANOVA was used. For intergroup comparison,\nindependent t-test was applied. Post-hoc bonferroni test is used if p value\n<0.05. p <0.05 is considered as statistically significant.<\/p>\n\n\n\n

Results<\/strong><\/p>\n\n\n\n

This\nstudy recruited seventy-two patients who were undergoing elective middle ear surgery\nunder local anesthesia. The drugs were allocated as per their respective group.\nThe Mean \u00b1 SD of age in years of\npatients in their respective group were calculated by using SPSS software version\n22. The\ndemographic data of 2 groups of patients was comparable. [Table 1]\n\n\n\n

Table 1: Patient demographic profile.<\/strong><\/p>\n\n\n\n\n\n\n\n\n
\n

 <\/p>\n<\/td>\n

\n

Group D<\/strong><\/p>\n<\/td>\n

\n

Group MF<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Age in Years (Mean \u00b1 SD)<\/p>\n<\/td>\n

\n

25.28\u00b17.21<\/p>\n<\/td>\n

\n

27.61\u00b17.86<\/p>\n<\/td>\n<\/tr>\n

\n

No. of females<\/p>\n<\/td>\n

\n

15 (41.67%)<\/p>\n<\/td>\n

\n

20 (55.55%)<\/p>\n<\/td>\n<\/tr>\n

\n

No. of males<\/p>\n<\/td>\n

\n

21 (58.33%)<\/p>\n<\/td>\n

\n

16 (44.44%)<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n

The MMSE score and Stroop color word interference test score were calculated at post-op 1,2,4 and 8 hour. On Intra group comparison at different time intervals showed a highly significant decline in MMSE score at 1 hour, 2 hour and 4 hour post operatively as compared to the baseline values in both the groups. At 8 hours post-operative period, no significant difference in MMSE score was seen as compared to baseline. However, on inter group comparison, the difference between the MMSE score were significant only at 1 & 2 hours post operatively. (Table 2).<\/p>\n\n\n\n

Table 2: MMSE and Stroop color word interference test score of patients<\/strong> <\/p>\n\n\n\n\n\n\n\n\n\n\n\n
\n

 <\/p>\n<\/td>\n

\n

Mini\u2013Mental State Examination score (Mean \u00b1 SD)<\/strong><\/p>\n<\/td>\n

\n

Stroop color word interference test score (Mean \u00b1 SD)<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

 <\/p>\n<\/td>\n

\n

Group D<\/strong><\/p>\n<\/td>\n

\n

Group MF<\/strong><\/p>\n<\/td>\n

\n

Inter group \u2013p value<\/strong><\/p>\n<\/td>\n

\n

Group D<\/strong><\/p>\n<\/td>\n

\n

Group MF<\/strong><\/p>\n<\/td>\n

\n

Inter group -p value<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Pre-op<\/p>\n<\/td>\n

\n

29.64\u00b10.639<\/p>\n<\/td>\n

\n

29.64\u00b10.543<\/p>\n<\/td>\n

\n

0.577<\/p>\n<\/td>\n

\n

53.06\u00b19.795<\/p>\n<\/td>\n

\n

52.72\u00b110.132<\/p>\n<\/td>\n

\n

0.725<\/p>\n<\/td>\n<\/tr>\n

\n

1 Hour Post-op<\/p>\n<\/td>\n

\n

26.22\u00b11.19##<\/p>\n<\/td>\n

\n

25.19\u00b11.43##<\/p>\n<\/td>\n

\n

0.016*<\/p>\n<\/td>\n

\n

35.03\u00b16.300##<\/p>\n<\/td>\n

\n

30.58\u00b15.469##<\/p>\n<\/td>\n

\n

0.445<\/p>\n<\/td>\n<\/tr>\n

\n

2 Hour Post-op<\/p>\n<\/td>\n

\n

27.58\u00b10.967##<\/p>\n<\/td>\n

\n

27.03\u00b11.32##<\/p>\n<\/td>\n

\n

0.001**<\/p>\n<\/td>\n

\n

38.53\u00b18.248##<\/p>\n<\/td>\n

\n

37.00\u00b15.575##<\/p>\n<\/td>\n

\n

0.011*<\/p>\n<\/td>\n<\/tr>\n

\n

4 Hour Post-op<\/p>\n<\/td>\n

\n

28.42\u00b10.996##<\/p>\n<\/td>\n

\n

27.94\u00b11.094##<\/p>\n<\/td>\n

\n

0.737<\/p>\n<\/td>\n

\n

43.83\u00b18.713##<\/p>\n<\/td>\n

\n

41.86\u00b17.507##<\/p>\n<\/td>\n

\n

0.389<\/p>\n<\/td>\n<\/tr>\n

\n

8 Hour Post-op<\/p>\n<\/td>\n

\n

29.94\u00b11.638<\/p>\n<\/td>\n

\n

29.31\u00b10.786<\/p>\n<\/td>\n

\n

0.663<\/p>\n<\/td>\n

\n

52.14\u00b19.550<\/p>\n<\/td>\n

\n

51.22\u00b19.574<\/p>\n<\/td>\n

\n

0.725<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

*  -Significant difference between the groups (p \u2264 0.05)<\/p>\n

** – Highly significant difference between the groups (p \u2264 0.001)<\/p>\n

## – Highly significant difference as compared to the baseline value (p \u2264 0.001)<\/p>\n\n\n

 5 patients in\nMF group had mild cognitive dysfunction (MMSE score 18-23) at 1 hour post-op\nperiod, as compared to only 1 such patient in D group. None of the patients\nshowed severe cognitive impairment (MMSE score 0-17) in any of the group at any\ntime interval.<\/p>\n\n\n\n

The results of the stroop color word interference test score are shown in Table 2. Although both the groups showed a highly significant decline in the stroop color word interference score at 1 hour, 2 hour & 4 hours, as compared to the baseline value, but in intergroup comparison, values were seen to be significantly different only at 2 hours post-op period. <\/p>\n\n\n\n

Table 3: Delirium assessment of patients. <\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n
\n

 <\/p>\n<\/td>\n

\n

No. of patients having delirium [n(%)]<\/strong><\/p>\n<\/td>\n

\n

Delirium severity scores of patients (Mean \u00b1 SD)<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

 <\/p>\n<\/td>\n

\n

Group D<\/p>\n<\/td>\n

\n

Group MF<\/p>\n<\/td>\n

\n

Group D<\/p>\n<\/td>\n

\n

Group MF<\/p>\n<\/td>\n

\n

P value<\/p>\n<\/td>\n<\/tr>\n

\n

Pre-op<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

 <\/p>\n<\/td>\n<\/tr>\n

\n

1 hr post-op<\/p>\n<\/td>\n

\n

4 (11.11%)<\/p>\n<\/td>\n

\n

10 (27.78 %)<\/p>\n<\/td>\n

\n

0.11\u00b10.319<\/p>\n<\/td>\n

\n

0.28\u00b10.454#<\/p>\n<\/td>\n

\n

<0.001**<\/p>\n<\/td>\n<\/tr>\n

\n

2 hr post-op<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

 <\/p>\n<\/td>\n<\/tr>\n

\n

4 hr post-op<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

 <\/p>\n<\/td>\n<\/tr>\n

\n

8 hr post-op<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

00<\/p>\n<\/td>\n

\n

 <\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

** – Highly significant difference between the groups (p \u2264 0.001).<\/p>\n

# – Significant difference as compared to the baseline value (0).<\/p>\n\n\n

Short CAM test results indicated that more number of\npatients showed signs of delirium in group MF (27.78%)as compared to group D\n(11.11%) at Post-op 1 hour. But no signs of delirium were found in any patient\nat post-op 2 hours, 4 hours and 8 hours in both the groups.<\/p>\n\n\n\n

When delirium\nwas present in any patient then the severity of delirium was assessed by Short\nCAM severity test score. Mean values of short-CAM severity scores are shown in\nTable 3. When we compare post-op 1 hour value with the pre-op value of 0, the\ndifference is significant in group MF; however it is not significant in group\nD.<\/p>\n\n\n\n

It is also evident that short-CAM severity score at post-op 1 hour is highly significantly more in group MF as compared to group D. The mean scores at all other time periods were 0 as no patient has delirium.<\/p>\n\n\n\n

Discussion <\/strong><\/p>\n\n\n\n

In this\nstudy, it was observed that dexmedetomidine and midazolam-fentanyl combination\nproduced highly significant decline in the cognitive status of the patient as\nseen by the MMSE and Stroop test scores till 4 hours post-op period. However,\nthe MMSE and stroop test score returned back to baseline in less than 8 hours\npost-op period. Drop in both the scores were significantly more in MF group\nfentanyl as compared to D group. Hence, it can be interpreted that\ndexmedetomidine produced less cognitive dysfunction in the patients as compared\nto midazolam and fentanyl combination till 2 hours post-op period. However,\nthere was no difference in the time taken for psychomotor recovery in both the\ngroups.<\/p>\n\n\n\n

Rajaei M et\nal. in 2019 also compared dexmedetomidine & midazolam for long term effects\non cognition in patients undergoing coronary artery bypass graft surgery.\nHowever, they did MMSE test, one day before surgery and repeated it 5 and 30\ndays after surgery. Results from this study were in favor of dexmedetomidine as\nthis group of patients had fewer signs of cognitive impairment than the\nmidazolam group, at 5 and 30 days after surgery.11<\/sup>Kermany MPN et. al\nin 2016, compared dexmedetomidine and remifentanil for their effects on\ncognitive state in 100 patients undergoing cataract surgery.MMSE scores post\noperatively and 120 minutes after drug discontinuation were recorded. The\nauthors concluded that dexmedetomidine is more suitable agent for sedation because\nit causes lesser impairment of cognitive function and better hemodynamic\nstability.12<\/sup>Perika T et. al compared dexmedetomidine and propofol\nfor psychomotor recovery after sedation during spinal anesthesia. In their\nstudy psychomotor recovery was assessed by a battery of tests, postoperatively half\nhourly for initial 2 hours and later by hourly assessment up to 4 hours. Psychomotor\nrecovery, in patients who received dexmedetomidine was achieved earlier as\ncompared to patients receiving propofol.13<\/sup><\/p>\n\n\n\n

In our study\ndelirium was assessed by Short CAM test and lesser number of patients from\nGroup D showed signs of delirium as compared to group MF at post-op 1 hour. But\nno signs of delirium were found in any patient later on. Similar results were\nalso obtained when Mean Short CAM delirium severity test score at post-op 1\nhour as compared to the pre-op value of 0. On intergroup comparison, mean Short-CAM\ndelirium severity score was significantly higher in group MF as compared to\ngroup D at 1 hour post-op period. However, all patients where delirium was\npresent, it was mild in severity, as evidenced by severity score of 1 in all of\nthem. Thus, we can interpret that both group of drugs produce only mild\ndelirium. However, chances of producing delirium are lower with dexmedetomidine\nas compared to Midazolam-fentanyl.<\/p>\n\n\n\n

A study\nconducted by Zhang W et al. in 2020 compared the effects of dexmedetomidine\nwith normal saline on post-operative delirium. The data from 218 patients\nrevealed that there is decreased incidence of post-operative delirium in\ndexmedetomidine group (18.2%) as compared to normal saline group (30.6%).14<\/sup>Thus\nthey concluded that dexmedetomidine might have a protective effect against\npost-op cognitive dysfunction. Similar findings were noted by Xian Su in 2011\nwho studied the effect of dexmedetomidine in elderly patients for prevention of\ndelirium during post operative period. Twice daily assessment of delirium with\nthe CAM for intensive care units (CAM-ICU) revealed\nthat prophylactic role of low-dose dexmedetomidine significantly decreased the\noccurrence of delirium during first 1 week of surgery.  during the first 7 days after surgery.15 <\/sup>Another\nstudy done by R R Riker in 2009, compared the effect of dexmedetomidine versus\nmidazolam in critically ill patients and concluded that the prevalence of\ndelirium during treatment was less in dexmedetomidine treated patients (54%) as\ncompared to in midazolam-treated patients (76.6%).16<\/sup>A study was done\nby Azeem TMA et al. in 2018 which compared the effect of dexmedetomidine with morphine\nand midazolam in patients of cardiac surgery. Prevalence of delirium was\nassessed in this study by using CAM-ICU. Assessment was done once daily until 7\ndays after surgery. This study concluded that incidence of postoperative\ndelirium caused by dexmedetomidine was not significantly different from\nmorphine and midazolam.17<\/sup> The results of our study differ from this\nstudy possibly due to longer follow-up and selection of patients from ICU. <\/p>\n\n\n\n

Thus the\neffect of dexmedetomidine on delirium is seen to be different in different\nstudies. Thus more studies might be needed to clear this confusion.<\/p>\n\n\n\n

Conclusion<\/strong><\/p>\n\n\n\n

The present study concluded that drug dexmedetomidine causes less cognitive decline and less chance of producing post-op delirium as compared to midazolam-fentanyl combination when used for sedation at the time of surgery.<\/p>\n\n\n\n

Conflict of Interest<\/strong><\/p>\n\n\n\n

There is no conflict of interest.<\/p>\n\n\n\n

Funding Sources<\/strong><\/p>\n\n\n\n

There are no funding sources.<\/p>\n\n\n\n

References<\/strong><\/p>\n\n\n\n

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