FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/10/016206 [Registered on: 30/10/2018] Trial Registered Prospectively
Last Modified On: 04/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare two drugs (dexmedetomidine and nitroglcerine) used to decrease blood pressure during operation in a controlled manner while using a technology (near infrared spectroscopy) to measure oxygen saturation in brain 
Scientific Title of Study   COMPARISON OF THE EFFECTS OF DEXMEDETOMIDINE AND NITROGLYCERIN ON CEREBRAL OXYGEN SATURATION USING NEAR INFRARED SPECTROSCOPY IN PATIENTS UNDERGOING CONTROLLED HYPOTENSIVE ANAESTHESIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati Chhabra 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences,Jodhpur. 
Address  Department of Anaesthesiology and Critical Care, AIIMS Basni industrial area phase 2 Jodhpur Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  7340033034  
Fax    
Email  swati_virgo83@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati Chhabra 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences,Jodhpur. 
Address  Department of Anaesthesiology and Critical Care, AIIMS Basni industrial area phase 2 Jodhpur Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  7340033034  
Fax    
Email  schhabra0209@gmail.com  
 
Details of Contact Person
Public Query  
Name  Koteshwar J Rao 
Designation  Post Graduate Student 
Affiliation  All India Institute of Medical Sciences,Jodhpur. 
Address  Flat A7, Ayushi Apartment Near Shubham Farms Pal Road, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  kotijyothi28@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology @ Critical Care AIIMS Basni industrial area phase 2 Jodhpur Rajasthan 342005 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Basni industrial area phase 2 Jodhpur Rajasthan 342005 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Swati Chhabra  AIIMS JODHPUR  Department of Anaesthesiology and Critical Care AIIMS Basni industrial area phase 2 Jodhpur Rajasthan 342005
Jodhpur
RAJASTHAN 		 7340033034

swati_virgo83@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, JODHPUR, Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Effects of dexmedetomidine and nitroglycerin on regional cerebral oxygen saturation during controlled hypotensive anesthesia using noninvasive near infrared spectroscopy for detection of cerebral desaturation events.   Upon arrival in operating room, ECG, non-invasive blood pressure, SpO2, BIS and NIRS will be attached and parameters will be noted.Maintenance of anaesthesia will be done with sevoflurane in O2/air mixture (FiO2 0.4) to achieve BIS value of 45-60.. The infusion of the study drugs is titrated to achieve MAP in the range of 55-65 mm Hg. Continuous monitoring of vitals (invasive MAP, SpO2, BIS, rScO2) will be done and will note cerebral desaturation by Near infrared spectroscopy. Cerebral desaturation events (CDEs), defined as 25% reduction in rScO2 from the baseline value for at least 15 seconds are recorded and intervened by checking the head position, ventilation (to achieve EtCO2 30-35 mm Hg), maintaining MAP within 55-65 mm Hg, increasing FiO2 and fluid administration. 
Comparator Agent  Group D(Dexmedetomidine) and Group N(Nitroglycerine) to receive dexmedetomidine and nitroglycerin respectively to achieve controlled hypotension.  Randomisation will be done using computer generated random numbers for allocation of patients into two groups (Group D and Group N) to receive dexmedetomidine and nitroglycerin respectively to achieve controlled hypotension. Two syringes will be prepared by a non participating person who will know the body weight of the patient and will load drug in two syringes labelled loading dose and maintenance dose of study drug. Loading dose of Group D will contain 1 mcg/kg of dexmedetomidine diluted in normal saline (NS) in a 10 ml syringe. Maintenance dose of dexmedetomidine will be prepared by diluting 200 mcg (2 ml) with 48 ml NS to a concentration of 4 mcg/ml. Loading dose of Group N will contain 10 ml of NS. Maintenance dose of nitroglycerin will be prepared by diluting 25 mg (5 ml) with 45 ml NS to a concentration of 500 mcg/ml. Since the recommended doses of dexmedetomidine and nitroglycerin infusion are 0.2 - 0.7 mcg/kg/hr and 0.5 - 2 mcg/kg/min respectively, these concentrations of the study drugs will roughly result in similar ranges of infusion rates (2.5 ml/h to 12 ml/h in a 50 kg patient) over which they can be titrated for achieving the goal of controlled hypotension 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists
(ASA) physical status I and II and scheduled to undergo surgery in supine position with
neutral head position, under general anaesthesia with controlled hypotension will be
enrolled for this randomised non-inferiority trial. 
 
ExclusionCriteria 
Details  Preexisting cerebral pathology,
Cognitive disability,
Carotid artery stenosis,
Cardiac disease,
Orthostatic hypotension,
Sensitivity to study drugs. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the occurrence of cerebral desaturation events caused by use of dexmedetomidine and nitroglycerin for controlled hypotensive anaesthesia.  30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effects of dexmedetomidine and nitroglycerin on
left and right regional cerebral oxygen saturation, haemodynamics (blood pressure and
heart rate) and postoperative cognitive decline, when used for controlled hypotensive
anaesthesia. 		 MMSE score will be re-evaluated after 3 days to look for postoperative cognitive decline
(POCD). Any decrease in score 2 points will be defined as POCD. 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/11/2018 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Controlled hypotension is frequently used during anaesthesia to target a mean arterial pressures between 55-65 mm Hg to decrease blood loss during surgeries and improve the visualisation of operative field. Many techniques have been used and compared in literature but with outcomes like amount of blood loss, surgeon’s satisfaction and recovery profiles. Near infrared spectroscopy (NIRS) has established role in measuring regional tissue oxygen saturation especially in the cerebral oxygen saturation (rScO2). It’s application has been limited in evaluating the effect of various drugs used for controlled hypotension during anaesthesia. This study will compare the effects of dexmedetomidine and nitroglycerin, two of the commonly used drugs for controlled hypotensive anaesthesia on rScO2, cerebral desaturation events and the interventions required. 

The two groups were comparable in terms of demographic profile, baseline haemodynamics and regional cerebral oxygen saturation. The difference in the heart rates in the two groups was statistically significant (p- value < 0.05) and considering a 95% confidence interval, it was more favourable towards Group D. The two groups were comparable in terms of mean arterial pressure and rScO2 at all the time points. There was no difference in the occurrence of CDE in the two groups. POCD could not be assessed in the patients on the third postoperative day since they were being discharges before that. Hence, MMSE scores were not captured in any of the patients.

To conclude, Dexmedetomidine is non inferior to nitroglycerin when used for controlled hypotensive anaesthesia (target MAP 55-65 mm of Hg) in surgeries of head and neck with head in neutral position and lasting less than two hours.

 
Close