| CTRI Number |
CTRI/2025/02/081076 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
comparing the effectiveness of oral Melatonin and Pregabalin in reducing blood pressure , heart rate while inserting tube during anaesthesia in patients undergoing Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
Comparative study of Melatonin versus Pregabalin in attenuation of Hemodynamic stress response to Laryngoscopy and Endotracheal intubation in Patients undergoing Laparoscopic Cholecystectomy - A Randomised Control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Sukhirtha S |
| Designation |
DNB Resident |
| Affiliation |
Narayana Health City |
| Address |
Department of Anaesthesiology, 4th floor Anaesthesia office,B block OT and SICU Complex,Mazumdar Shah Medical Centre, Narayana Health city,Bommasandra, Bangalore
Bangalore KARNATAKA 560099 India |
| Phone |
9842351355 |
| Fax |
|
| Email |
sukhirtha.s.dr@narayanahealth.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shwetha N Reddy |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Narayana Health City |
| Address |
Department of Anaesthesiology, 4th floor Anaesthesia office,B block OT and SICU complex,Mazumdar Shah Medical Centre, Narayana Health city,Bommasandra, Bangalore
Bangalore KARNATAKA 560099 India |
| Phone |
9972323333 |
| Fax |
|
| Email |
drshwereddy@outlook.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sukhirtha S |
| Designation |
DNB Resident |
| Affiliation |
Narayana Health City |
| Address |
Department of Anaesthesiology, 4th floor Anaesthesia office,B block OT and SICU complex,Mazumdar Shah Medical Centre, Narayana Health city,Bommasandra, Bangalore
Bangalore KARNATAKA 560099 India |
| Phone |
9842351355 |
| Fax |
|
| Email |
sukhirtha.s.dr@narayanahealth.org |
|
|
Source of Monetary or Material Support
|
| Narayana Hrudayalaya Hospital, Bommasandra, Bangalore , Karnataka, India Pin-560099 |
|
|
Primary Sponsor
|
| Name |
Narayana Hrudayalaya Hospital |
| Address |
Narayana Hrudayalaya Hospital, Bommasandra, Bangalore , Karnataka, India Pin-560099 |
| 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 Sukhirtha S |
Narayana Health city |
Department of Anaesthesiology, 4th floor Anaesthesia office, B block OT and SICU complex,Mazumdar Shah Medical Centre, Narayana Health city,Bommasandra, Bangalore Bangalore KARNATAKA |
9842351355
sukhirtha.s.dr@narayanahealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NARAYANA HEALTH ACADEMIC ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Attenuation of stress response during intubation |
Patients posted for laparoscopic cholecystectomy will be considered for the study. These patients will be randomly divided and Group M will be given oral Melatonin 6mg and Group P will be given oral Pregabalin 150mg 2 hours prior to the surgery. |
| Comparator Agent |
Melatonin |
Giving Melatonin 6mg orally 2 hours prior to surgery and comparing its efficacy in reducing stress response to intubation with Pregabalin 150mg given orally 2 hours prior to surgery and monitoring blood pressure, heart rate, saturation, sedation score before , during and after intubation for 15min and one hour after extubation |
| Comparator Agent |
Pregabalin |
Giving orally Pregabalin 150mg 2 hours prior to surgery and comparing its efficacy in reducing stress response to intubation with Melatonin 6mg given orally 2 hours prior to surgery monitoring blood pressure, heart rate, saturation, sedation score before , during and after intubation for 15min and one hour after extubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of American society of Anaesthesiologists (ASA) physical status Grade I, II and III |
|
| ExclusionCriteria |
| Details |
Patients with Psychiatric illness,Sleep disorders, Drug allergy, anticipated difficult airway are excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing stress response during Endotracheal intubation |
Blood pressure, Heart rate , Mean arterial Pressure, Sedation score are monitored before, at the time and after intubation till 15 minutes and one hour post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect on Sedation |
Pre operative & Post extubation sedation will be monitored using Ramsay sedation score |
|
|
Target Sample Size
|
Total Sample Size="114" Sample Size from India="114"
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)
|
03/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laryngoscopy and intubation are painful stimuli which invoke responses like tachycardia, hypertension and arrythmias. The hemodynamic stress response resulting from airway instrumentation are due to sympatho-adrenergic response caused by epi-pharyngeal and parapharyngeal stimulations which lead to rise in catecholamine level that increases blood pressure and heart rate. These Hemodynamic responses may be fatal in patients with coronary artery disease, hypertension, intracranial aneurysm, cerebrovascular disease and may cause MI, arrythmias, left ventricle failure and rupture of aneurysm. MELATONIN (N-acetyl-5-methoxytryptamine) is a endogenous sleep regulating hormone secreted by pineal gland. Exogenous administration of melatonin facilitates sleep and improves quality of sleep. It is different from benzodiazepines and their derivatives in that it produces natural sleep pattern and doesn’t lead impairment of cognitive functions. This drug has been mainly studied as sedative agent in intensive care unit and preoperatively as anxiolytic agent. PREGABALIN a gabapentinoid compound appears to produce an inhibitory modulation of neuronal excitability particularly neocortex, amygdala, hippocampus of CNS. It binds to the a2d subunit of voltage dependent calcium channels and inhibits the channel. It possesses analgesic, anticonvulsant and anxiolytic activity by reduction of neurotransmitter glutamate, nor-adrenaline, serotonin, dopamine and substance P. |