| CTRI Number |
CTRI/2021/05/033894 [Registered on: 31/05/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO COMPARE HAEMODYNAMIC STABILITY OF CLONIDINE AND MAGNESIUM SULPHATE DURING PNEUMOPERITONEUM IN LAPAROSCOPIC CHOLECYSTECTOMY |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF INTRAVENOUSLY ADMINISTERED CLONIDINE AND MAGNESIUM SULPHATE IN ATTENUATING HEMODYNAMIC RESPONSE TO PNEUMOPERITONEUM DURING LAPAROSCOPIC CHOLECYSTECTOMY
RANDOMISED BLINDED COMPARATIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharon Aylmer Lamare Rymbai |
| Designation |
Secondary DNB(T), Anaesthesiology |
| Affiliation |
Private organisation |
| Address |
Nazareth Hospital,
Department of Anaesthesia and Critical care,
Laitumkhrah, Shillong
East Khasi Hills District,
Nazareth Hospital,
Department of Anaesthesia and Critical care
Laitumkhrah, Shillong
East Khasi Hills District,
Meghalaya
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
9654157080 |
| Fax |
|
| Email |
dr.sharon77@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himjyoti Das |
| Designation |
Senior Consultant and Head of the department |
| Affiliation |
Private institute / organisation |
| Address |
Nazareth Hospital,
Department of Anaesthesia and Critical Care,
Laitumkhrah, Shillong
East Khasi Hills District,
Nazareth Hospital,
Department of Anaesthesia and Critical Care,
Laitumkhrah, Shillong
East Khasi Hills District,
Meghalaya
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
9862018017 |
| Fax |
|
| Email |
himjyotidas@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharon Aylmer Lamare Rymbai |
| Designation |
Secondary DNB(T), Anaesthesiology |
| Affiliation |
Nazareth Hospital, Shillong |
| Address |
Nazareth Hospital,
Department of Anaesthesia and Critical Care
Laitumkhrah, Shillong
East Khasi Hills District,
Nazareth Hospital,
Department of Anaesthesia and Critical Care
Laitumkhrah, Shillong
East Khasi Hills District,
Meghalaya
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
9654157080 |
| Fax |
|
| Email |
dr.sharon77@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Nazareth hospital,Shillong |
|
|
Primary Sponsor
|
| Name |
Nazareth Hospital |
| Address |
LAITUMKHRAH, SHILLONG
EAST KHASI HILLS
MEGHALAYA- 793003 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Sharon Aylmer Lamare Rymbai |
Nazareth hopsital |
Department of Anaesthesia and Critical Care,
Laitumkhrah
Shillong
East Khasi Hills
MEGHALAYA |
9654157080
dr.sharon77@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NAZARETH HOSPITAL, SHILLONG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (3) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (4) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (5) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (6) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (7) ICD-10 Condition: K810||Acute cholecystitis, (8) ICD-10 Condition: K811||Chronic cholecystitis, (9) ICD-10 Condition: K824||Cholesterolosis of gallbladder, (10) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis, (11) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
clonidine |
CLONIDINE 1.5 mcg/kg in 100 ml NS over 15 mins immediately after intubation in general anaesthesia and prior to creation of pneumoperitoneum |
| Comparator Agent |
Magnesium sulphate |
magnesium sulphate 50 mg/kg in 100 ml NS over 15 mins immediately after intubation in general anaesthesia and prior to creation of pneumoperitoneum |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and ASA II
Both gender in the agr group of 18-60 years
Patients posted for elective laparoscopic cholecystectomy
|
|
| ExclusionCriteria |
| Details |
- Patients who refused to give informed written consent
-Patients with known allergy to magnesium sulphate and clonidine
- Pregnant patients posted for lapascopic cholecystectomy |
|
|
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 |
Primary objective:
The aim of this study will be to compare the effect of IV administered Clonidine and Magnesium sulphate on hemodynamic response during pneumoperitoneum in laparoscopic cholecystectomy |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of adverse effects like hypotension, bradycardia(intra-operatively),nausea,vomiting,and shivering. Level of sedation immediately after extubation in both the groups will be assessed using Modified Ramsay Sedation Score |
6 months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomized blinded comparative study will be conducted on 68 patients belonging to ASA I and II undergoing elective laparoscopic cholecystectomy. Patients of both gender ranging between 18 to 60 years of age will be included. Our aim will be to evaluate and compare the effect of intravenously administered clonidine at 1.5 mcg/kg and magnesium sulphate at 50 mg/kg for attenuating the hemodynamic response to pneumoperitoneum during laparoscopic cholecystectomy. Patients will be divided randomly into two groups of 34 each. Group A will receive IV Inj. Clonidine 1.5 mcg/kg in 100 ml of NS over 10 mins and Group B will receive Inj. Magnesium sulphate 50 mg/kg in 100 ml of NS over 10 mins. Randomization will be done by using a computer generated randomization table in blocks of four, and a ratio of 1:1 that placed patients into 2 groups equally. The test drug solution will be given after intubation and before pneumoperitoneum creation. The heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, EtCO2, oxygen saturation, adverse effects and level of sedation will be assessed by Modified Ramsay sedation score in both groups. The data collected will be analysed using IBM SPSS 22. Line diagram will be drawn for parameters like heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure. The results will be obtained in the form of range, mean and standard deviation. t- test will be conducted for comparison of means. ANOVA test will be conducted. The ‘p’ value of <0.05 will be considered statistically significant |