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
|
|
Primary Sponsor
|
Name |
SGPGI |
Address |
Raebarelli road, Lucknow |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
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
|
|
Health Condition / Problems Studied
Modification(s)
|
|
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
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