FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/01/004268 [Registered on: 01/01/2014] Trial Registered Retrospectively
Last Modified On: 01/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of continuous intravenous infusion of dexmedetomidine and esmolol on patients hemodynamics and pain after operation in laproscopic urological surgeries. 
Scientific Title of Study   Effect of continuous infusion of dexmedetomidine and esmolol on hemodynamic attenuation and post operative analgesic requirement in patients undergoing laproscopic urological surgeries 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Srivastava 
Designation  Senior Resident 
Affiliation  Sanjay Gandhi Post Graduate Institute, Lucknow. 
Address  Dept. of Anesthesiology, Block A, SGPGIMS, Raebareli Road, Lucknow.

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904439  
Fax    
Email  dr.divshri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Sahu 
Designation  Associate Proffesor 
Affiliation  Sanjay Gandhi Post Graduate Institute, Lucknow. 
Address  Dept. of Anesthesiology, Block A, SGPGIMS, Raebareli Road, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904598  
Fax    
Email  drsandeepsahu@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Divya Srivastava 
Designation  Senior Resident 
Affiliation  Sanjay Gandhi Post Graduate Institute, Lucknow. 
Address  Dept. of Anesthesiology, Block A, SGPGIMS, Raebareli Road, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone    
Fax    
Email  dr.divshri@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  SGPGI 
Address  Raebarelli road, Lucknow 
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 Divya Srivastava  Urology Operation Theatre  OT Complex, Block F, SGPGIMS, Lucknow
Lucknow
UTTAR PRADESH 
8004904439

dr.divshri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGPGI Institute Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine infusion.  Induction with 1ug/kg over 15 mins, then 0.5ug/kg/hr, intravenously during intraoperative period. 
Comparator Agent  Esmolol infusion  Induction with 1mg/kg over 10 min then infusion of 15ug/kg/min, intravenously during intraoperative period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients undergoing laparoscopic urological procedures.
Surgeries to be included: Laparoscopic donor nephrectomy, lap simple nephrectomies, and lap pyeloplasty.
 
 
ExclusionCriteria 
Details  1.Consent not given.
2.ASA physical status III and more,
3.History of hepatic, renal, or cardiac failure, organ transplant,
4.History of diabetes, morbid obesity (body mass index > 40),
5.Chronic use of opioids or ß adrenergic receptor antagonists,
6.Known asthma or reactive airway disease,
7.Severe mental impairment,
8.Allergy to any of two drugs, or
9.Inability to comprehend pain assessment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the hemodynamic effects of dexmedetomidine and esmolol infusions,
To compare postoperative requirement of opioids in both groups. 
During intraoperative period.
24 hrs postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time of awakening and extubation after stopping anesthetic agent
 
Immediately after operation
 
To compare nausea and vomiting and requirement of antiemetic in post operative period.  Immediate postopaerative period till 24hrs postoperatively 

To study the occurrence of side effects with use of these drugs. 
Intraoperative and 24hrs postoperatively 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/12/2013 
Date of Study Completion (India) 29/05/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/08/2017 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Introduction

Laparoscopic surgeries in general are associated with increased hemodynamic responses and the anesthesiologists are required to either increase anesthetic depths to supranormal levels or take help of vasodilator drugs or anesthetic adjuvants. Both α2 antagonists and ß blockers have been used in previous studies for the same purpose.1,2,3. Dexmedetomidine is a α2 antagonist4 and esmolol is ultra short acting ß blocker. Use of both of these drugs has never been described for laparoscopic urological surgeries. We will compare the role of continuous infusion of above both drugs and their adverse effects in laparoscopic urological surgeries.

METHODS:

After informed written consent we are planning to study patients undergoing laparoscopic urological surgeries. All the patients will receive balanced general anesthesia with endotracheal intubation and mechanical ventilation in similar pattern as per protocol. They will be divided randomly into two groups.

Group D: receiving Dexmedetomidine 1ug/kg loading dose over 15 minutes then an infusion of@ 0.5ug/kg/hr.

Group E : receiving esmolol loading dose 1 mg/kg over 15 minutes then @15 ug/kg/hr.

 Isoflurane will be titrated to keep pulse and blood pressure within 25% of baseline, by keeping Bispectral Index(BIS) <60 at all times. Injection atropine 0.03 mg bolus will be given for bradycardia and injection mephentermine 6mg bolus for hypotension greater than 25% of baseline and not improving with decreasing isoflurane and fluid boluses. At the end of surgery patient will be extubated and shifted to post op recovery room.

MEASUREMENTS: Pulse and Blood pressure of patient will be taken at baseline, at intubation , on starting drug, at CO2 insufflations, then every 15 mins, at stopping drug, at extubation and in post operative. Duration of surgery, total fentanyl used, time to awakening and time of extubation, sedation scores, pain scores, post operative analgesic requirement, nausea and requirement of antiemetic in post operative will be studied.

Sample size calculation:  There are three parameters of primary objective viz; heart rate, blood pressure and post operative requirement of fentanyl in the recovery room. The variable total fentanyl used is used for sample size calculation. Considering the significance level α = 0.05 and power of the test as 0.9 (90%), a standard deviation of 75 ug in the variable total fentanyl required and critical difference between two drugs taken as 50 ug, the number of cases per group was 45 patients.

  1. Poonam S Ghodhi, Shalini K Thombre, Shalini P Sardesai, Kalpana D Harnagle. Dexmedetomidine as an anesthetic adjuvant in laparoscopic surgery: An observational study using entropy monitoring. J Anaesthesiol Clin Pharmacol. 2012 Jul-Sep; 28(3): 334–338

2.Koivusalo AM, Scheinin M, Tikkanen I, et al. Effects of esmolol on hemodynamic response to CO2 pneumoperitoneum for laparoscopic surgery. Acta Anaesthiol Scand 1998; 42: 510–7

3.Collard V, Mistraletti G, Taqi A, FranciscoJ et al Intraoperative Esmolol Infusion in the Absence of Opioids Spares Postoperative Fentanyl in Patients Undergoing Ambulatory Laparoscopic Cholecystectomy Anesth Analg 2007;105:1255–62.

  4. Bloor BC, Ward DS, Belleville JP, Maze M: Effects of intravenous dexmedetomidine in humans: II. Hemodynamic changes Anesthesiology 1992; 77: 1134–42


 
Close