| CTRI Number |
CTRI/2018/06/014675 [Registered on: 29/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of clonidine and pregabalin in reducing heart rate and blood pressure while placement of tube in windpipe during surgery for gall bladder removal. |
|
Scientific Title of Study
|
A comparative evaluation of oral pregabalin and clonidine for attenuation of haemodynamic response to laryngoscopy and tracheal intubation during laparoscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajneesh Choudhary |
| Designation |
Postgraduate |
| Affiliation |
V.M.M.C. and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care,
Vardhman Mahavir Medical College and Safdarjung Hospital,
New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9716930584 |
| Fax |
|
| Email |
rajneesh.choudharypg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H C Sachdeva |
| Designation |
Consultant and Professor |
| Affiliation |
V.M.M.C. and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care,
Vardhman Mahavir Medical College and Safdarjung Hospital,
New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9868159563 |
| Fax |
|
| Email |
sachdeva_hc04@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H C Sachdeva |
| Designation |
Consultant and Professor |
| Affiliation |
V.M.M.C. and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care,
Vardhman Mahavir Medical College and Safdarjung Hospital,
New Delhi - 110029
New Delhi
DELHI
110029
India |
| Phone |
9868159563 |
| Fax |
|
| Email |
sachdeva_hc04@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi |
| Address |
Department of Anaesthesiology and Intensive Care,
Vardhman Mahavir Medical College and Safdarjung Hospital,
New Delhi -110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Rajneesh Choudhary |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi - 110029 |
Department of Anaesthesiology and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi -110029
New Delhi
DELHI |
9716930584
rajneesh.choudharypg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing elective Laparoscopic Cholecystectomy.
ASA I and II.
Age between 18 to 65 years.
Patients of Either Sex., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tablet Clonidine |
oral tablet of 0.2 mg, 90 minutes before surgery with a sip of water |
| Comparator Agent |
Tablet Pregabalin |
oral tablet of 75 mg, 90 minutes before surgery with a sip of water. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing elective Laparoscopic cholecystectomy.
ASA I and II.
|
|
| ExclusionCriteria |
| Details |
Anticipated difficult intubation.
BMI more than 30.
Patient concomitantly on Clonidine or Pregabalin or on Anti hypertensive drugs, Sedatives or hypnotics.
Patients with history of cardiovascular , cerebrovascular, neurological and respiratory disease, renal and hepatic dysfunction.
Patients with history of allergic reactions to any of the study drugs. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of oral pregabalin and Clonidine in attenuating the hemodynamic responses to laryngoscopy and intubation. |
Before premedication (T0).
Preinduction (TPREI).
Immediately after induction (TP0I).
3 minute after induction (TP0I3).
1(TT1), 3(TT3), 5(TT5) and 10(TT10) minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of Oral pregabalin and clonidine in attenuating the hemodynamic responses to laryngoscopy and intubation |
Before premedication.
Preinduction.
Immediately after induction.
3 minute after induction.
1, 3, 5and 10minutes after intubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
21/01/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Kovac AL et al. Controlling the hemodynamic response to laryngoscopy and endotracheal intubation. J Clin Anesth. 1996 Feb;8(1):63-79.
Gupta K, Sharma D, Gupta PK. Oral premedication with pregabalin or clonidine for hemodynamic stability during laryngoscopy and laparoscopic cholecystectomy: A comparative evaluation. Saudi J Anaesth 2011;5:179-84.
Tripathi DC, Shah KS, Dubey SR, Doshi SM, Raval PV. Hemodynamic stress response during laparoscopic cholecystectomy: Effect of two different doses of intravenous clonidine premedication. J Anaesthesiol Clin Pharmacol 2011;27:475-80.
Singhal SK, Kaur K, Arora P. Oral clonidine versus gabapentin as premedicant for obtunding hemodynamic response to laryngoscopy and tracheal intubation. Saudi J Anaesth 2014;8:172-7. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study is designed to compare the efficacy of oral pregabalin vs clonidine for attenuation of haemodynamic response to laryngoscopy and tracheal intubation in patients undergoing laparoscopic cholecystectomy under general anaesthesia. Haemodynamic changes (HR, SBP, DBP, MAP) following laryngoscopy and intubation will be recorded and compared between the groups. The study is conducted in 80 patients aged 18-65 years with ASA grade 1 or 2 of both gender admitted in VMMC and Safdarjung hospital. patients are divided into two groups, group P - pregabalin and group C - clonidine. patient in group P will receive 75mg oral pregabalin tablet and in group C will receive 200mcg clonidine tablet 90 minutes before surgery with sip of water. A detailed preanaesthetic evaluation including all routine investigations as guide by age will be carried out in all patients. Patients excluded from the study are: 1-anticipated difficult airway. 2-subjects with BMI>30. 3-patients concomitantly on clonidine or pregabalin or consumption of antihypertensive drugs, sedatives or hypnotics. 4-patients with history of cardiovascular, cerebrovascular, neurological and respiratory, renal and hepatic dysfunction. 5-patients with history of allergic reaction to any of the study drugs. In OT, standard monitoring including Spo2, NIBP, ECG, HR and sedation level will also be noted. patient will be given fentanyl 2mcg/kg IV and after 3-5 minutes induced with propofol 2-2.5mg/kg IV followed by injection Vecuronium 0.1mg/kg, IPPV with N2O with O2 with isoflurane 0.6% at flow rate of 6L/min, 3 minutes later laryngoscopy and intubation will be performed. haemodynamic parameters will be noted before induction, immediately after induction, 3 minutes after induction and 1,3,5 and 10 minutes after intubation. Anesthesia will be maintained with 66% N2O with O2 and isoflurane 0.6%. At the end of surgery, inhalational anaesthetic agent will be stopped, neuromuscular blockade reversed with inj glycopyrolate 0.01mg/kg and inj neostigmine 0.05mg/kg and trachea extubated. patient will be shifted to postoperative care unit when fully conscious and vitals stable. |