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CTRI Number  CTRI/2014/02/004376 [Registered on: 03/02/2014] Trial Registered Retrospectively
Last Modified On: 14/09/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A CLINICAL TRIAL COMPARING DEXMEDETOMIDINE AND MIDAZOLAM AS INTRAVENOUS SEDATIVE DURING SPINAL ANAESTHESIA. 
Scientific Title of Study   COMPARISON OF DEXMEDETOMIDINE WITH MIDAZOLAM REGARDING AROUSAL TIME FROM INTRAOPERATIVE SEDATION IN ADULT PATIENTS DURING SPINAL ANAESTHESIA FOR INFRAUMBILICAL SURGERIES. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SREYYA GANGULY 
Designation  Post Graduate Trainee 
Affiliation  NORTH BENGAL MEDICAL COLLEGE 
Address  Department of Anaesthesiology NORTH BENGAL MEDICAL COLLEGE PO SUSRUTANAGAR DIST DARJEELING STATE WEST BENGAL PIN 734012
NORTH BENGAL MEDICAL COLLEGE PO SUSRUTANAGAR DIST DARJEELING STATE WEST BENGAL PIN 734012
Darjiling
WEST BENGAL
734012
India 
Phone  9477412643  
Fax    
Email  shreyaganguly1986@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MOHAN CHANDRA MANDAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Department of Anaesthesiology 
Address  A-5, M.O. Qtrs, NORTH BENGAL MEDICAL COLLEGE PO SUSRUTANAGAR DIST DARJEELING STATE WEST BENGAL
NORTH BENGAL MEDICAL COLLEGE PO SUSRUTANAGAR DIST DARJEELING STATE WEST BENGAL PIN 734012
Darjiling
WEST BENGAL
734012
India 
Phone  9474084286  
Fax    
Email  drmcmandal@gmail.com  
 
Details of Contact Person
Public Query  
Name  SREYYA GANGULY 
Designation  Post Graduate Trainee 
Affiliation  NORTH BENGAL MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIOLOGY NORTH BENGAL MEDICAL COLLEGE PO SUSRUTANAGAR DIST DARJEELING STATE WEST BENGAL PIN 734012
NORTH BENGAL MEDICAL COLLEGE PO SUSRUTANAGAR DIST DARJEELING STATE WEST BENGAL PIN 734012
Darjiling
WEST BENGAL
734012
India 
Phone  9477412643  
Fax    
Email  shreyaganguly1986@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, North Bengal Medical College, Shusrutanagar, Siliguri, Darjeeling, West Bengal, India. 
 
Primary Sponsor  
Name  North Bengal Medical College and Hospital 
Address  DEPARTMENT OF ANAESTHESIOLOGY NORTH BENGAL MEDICAL COLLEGE Siliguri Dist- Darjeeling State- West Bengal India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sreyya Ganguly  Department of Anaesthesia, North Bengal Medical College  Shushrutnagar, Siliguri.
Darjiling
WEST BENGAL 		 9477412643

shreyaganguly1986@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, North BEngal Medical College, Darjeeling.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA physical status I and II of either sex, aged between 18-45 years ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DEXMEDOTOMIDINE  DETAILS:0.5 mcg/kg- loading dose over 10 minutes followed by infusion at a rate of 0.5 mcg/kg/h, intravenously.  
Comparator Agent  MIDAZOLAM  DETAILS 0.5 mg/kg-loading dose over 10 minutes followed by infusion at a rate of 0.05 mg/kg/h, intravenously.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  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.  
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The time to awakening from sedation (with dexmedetomidine or midazolam) utilizing
(i) Bispectral Index Score (BIS)14,
(ii) Observer Assessment of Alertness/Sedation (OAAS/S) Score
 		 TIME TO ACHIEVE BIS 90 FROM STOPPING INFUSION
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time taken for onset of sedation to attain a BIS score 70.
2. OAA/S scores at BIS scores of 70 and 90.
3. Intraoperative haemodynamic parameters (Mean arterial pressure, Heart rate).
4. Intraoperative respiratory parameters (SpO2,Respiratory rate).
5. Patients’ satisfaction regarding quality of intraoperative sedation.
6. Incidences of adverse events if any.
 		 every 10 mins until operation is over.  
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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

Midazolam is a short-acting benzodiazepine3 having the onset of action of 2-2.5 minutes after intravenous (i.v.) injection and also has a rapid offset of action3. It produces anxiolysis, sedation, amnesia and if used judiciously, may cause less respiratory depression. Midazolam is frequently used for sedation during spinal anaesthesia and also for ICU sedation4.

In quest of a better sedative having the property of rapid onset of sedation with easy arousability, dexmedetomidine5, a new α2 adrenergic receptor agonist, has gained popularity recently. Dexmedetomidine is now being used widely as a primary sedative anaesthetic agent during regional and general anaesthesia for 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 midazolam 8,9 have been observed in a few studies. Only few studies 10-13 have compared sedative effects of both the drugs. Only one study has compared the arousal times between the two drugs13. However, the arousal time was not the main focus of their observation.

Hence, this prospective randomized double blind study has been designed to compare the arousal time from intraoperative sedation with dexmedetomidine and midazolam during spinal anaesthesia 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 two groups of patients sedated with either dexmedetomidine or midazolam.

REFERENCES:

  1. 1.      Manara AR, Smith DC, Nixon C. Sedation during spinal anaesthesia: a case for the routine administration of oxygen. Br J Anaesth 1989; 63: 343-45.

    2.      Ho¨hener D, Blumenthal S, Borgeat A. Sedation and 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. The role of the alpha2-adrenoceptor agonist dexmedetomidine in postsurgical sedation in 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 Livingstone Elsevier; 2010.  p719-53.

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

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

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

    9.      Yaddanapudi S, Batra YK, Balagopal A, Nagdeve NG. Sedation in patients above 60 years of age undergoing urological surgery under spinal anesthesia: Comparison of propofol and midazolam infusions. J Postgrad Med 2007; 53: 171-5.

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

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

    12.  Celik M, Koltka N, 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 in gynecologic 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.

 
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