A CLINICAL TRIAL COMPARING DEXMEDETOMIDINE AND MIDAZOLAM AS INTRAVENOUS SEDATIVE DURING SPINAL ANAESTHESIA.

Completed

• Conditions: ASA physical status I and II of either sex, aged between 18-45 years

• Registration Number: CTRI/2014/02/004376
• Lead Sponsor: North Bengal Medical College and Hospital

Brief Summary

Intraoperative sedation alleviates anxiety,increases acceptance of regional anaesthesia. As such, using a sedative forthis purpose is emerging as a standard protocol nowadays, to alleviatepatient’s anxiety and to produce amnesia1 of the surgical procedure.Besides propofol, nowadays, midazolam and dexmedetomidine are being usedfrequently for sedation during regional anaesthesia2.

Midazolam is a short-actingbenzodiazepine3 having the onset of action of 2-2.5 minutes afterintravenous (i.v.) injection and also has a rapid offset of action3.It produces anxiolysis, sedation, amnesia and if used judiciously, may causeless respiratory depression. Midazolam is frequently used for sedation duringspinal anaesthesia and also for ICU sedation4.

In quest of a better sedativehaving the property of rapid onset of sedation with easy arousability,dexmedetomidine5, a new α2 adrenergic receptor agonist, has gainedpopularity recently. Dexmedetomidine is now being used widelyas a primary sedative anaesthetic agent during regional and general anaesthesiafor various surgeries and also for monitored anaesthesia care due to its sedative,hypnotic, analgesic property5,6,7.

The arousal time from sedation with dexmedetomidine 6,7or midazolam8,9 have been observed in a few studies. Only few studies 10-13have compared sedative effects of both the drugs. Only one study has comparedthe arousal times between the two drugs13. However, the arousal timewas not the main focus of their observation.

Hence, this prospectiverandomized double blind study has been designed to compare the arousal time fromintraoperative sedation with dexmedetomidine and midazolam during spinalanaesthesia for infra-umbilical surgeries. Additionally, the Observer Assessment of Alertness/Sedation(OAAS/S) Score2  observed at Bi-spectral index (BIS)14  value of 70 will be compared between the twogroups of patients sedated with either dexmedetomidine or midazolam.

**REFERENCES:**

1. 1.     Manara AR, Smith DC, Nixon C. Sedation duringspinal anaesthesia: a case for the routine administration of oxygen. Br J Anaesth1989; 63: 343-45.

2.     Ho¨hener D, Blumenthal S, Borgeat A. Sedationand regional anaesthesia in the adult patient. Br J Anaesth 2008; 100: 8–16.

3.     Reeves JG, Fragen RJ, Vinik HR, Greenblatt DJ.Midazolam: Pharmacology and Uses. Anesthesiology 1985; 62: 310-24.

4.     Martin E, Ramsay G, Mantz J, Sum-Ping ST. Therole of the alpha2-adrenoceptor agonist dexmedetomidine in postsurgical sedationin the intensive care unit. J Intensive Care Med 2003; 18(1): 29-41.

5.     Reeves JG,Glass P, Lubarsky DA, McEvoy MD, Marinez-Luiz R. Intravenous anesthetics. In:Miller RD (ed.). Miller’s anesthesia. 7th ed. Philadelphia: Churchill LivingstoneElsevier; 2010.  p719-53.

6.     Hall JE, Uhrich TD, Barney JA, Arain SR, EbertTJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidineinfusions. Anesth Analg 2000; 90: 699-705.

7.     Candiotti KA, Bergese SD, Bokesch PM, FeldmanMA, Wisemandle W, Bekker AY. Monitored anesthesia care with dexmedetomidine: aprospective, randomized, double-blind, multicenter trial. Anesth Analg 2010;110: 47-56.

8.     Khurana P, AgarwalA, Verma RK, Gupta PK. Comparison of midazolam and propofol for BIS-guided sedationduring regional anaesthesia. Indian J Anaesth 2009; 53(6): 662-6.

9.     Yaddanapudi S, Batra YK, Balagopal A, NagdeveNG. Sedation in patients above 60 years of age undergoing urological surgeryunder spinal anesthesia: Comparison of propofol and midazolam infusions. J PostgradMed 2007; 53: 171-5.

10. Alhashemi JA.  Dexmedetomidine vs midazolam for monitoredanaesthesia care during cataract surgery. Br J Anaesth 2006; 96: 722–6.

11. Apan A,Doganci N, Ergan A, Buyukkocak U. Bispectral index-guided intraoperativesedation with dexmedetomidine and midazolam infusion in outpatient cataractsurgery. Minerva Anesthesiol 2009; 75: 239-44.

12. Celik M, KoltkaN, Cevik B, Baba H. Intraoperative sedation during epidural anesthesia:dexmedetomidine vs midazolam. The Internet Journal of Anesthesiology 2008; 17 DOI:10.5580/27d2.

13. Liang Y, Gu M,Wanga S, Chua H. A comparison of dexmedetomidine and midazolam for sedation ingynecologic surgery under epidural anesthesia. J Curr Surg 2011; 1:12-18.

14. Sinha PK, Koshy T. Monitoring devices for measuring the depth of anaesthesia – an overview.Indian J Anaesth 2007; 51: 365-81.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-07
• Last Update Posted: 2014-09-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

ASA physical status I and II of either sex, aged between 18-45 years scheduled to undergo elective infraumbilical surgeries under spinal anaesthesia of approximate duration of 2 hours.

Exclusion Criteria

a.Patient not willing to accept spinal anaesthesia b.Patient not willing to receive sedation during surgery under spinal anaesthesia c.Patient not willing to participate in the study d.Patient having any of the following— I.neurological disease II.local infection at the site of inducing the block III.spinal deformity, past history of spine surgery or trauma IV.coagulopathy V.psychiatric illness VI.any history of allergy to the drugs to be used for the study VII.any significant cardiovascular and pulmonary disease VIII.impaired liver or kidney function IX.drug or alcohol use X.pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time to awakening from sedation (with dexmedetomidine or midazolam) utilizing	TIME TO ACHIEVE BIS 90 FROM STOPPING INFUSION
(i) Bispectral Index Score (BIS)14,	TIME TO ACHIEVE BIS 90 FROM STOPPING INFUSION
(ii) Observer Assessment of Alertness/Sedation (OAAS/S) Score	TIME TO ACHIEVE BIS 90 FROM STOPPING INFUSION

Secondary Outcome Measures

Name	Time	Method
1.Time taken for onset of sedation to attain a BIS score 70.	2.OAA/S scores at BIS scores of 70 and 90.

Trial Locations

Locations (1)

Department of Anaesthesia, North Bengal Medical College; 🇮🇳 Darjiling, WEST BENGAL, India

Department of Anaesthesia, North Bengal Medical College

🇮🇳Darjiling, WEST BENGAL, India

Sreyya Ganguly

Principal investigator

9477412643

shreyaganguly1986@gmail.com