| CTRI Number |
CTRI/2025/02/080851 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the impact of intraoperative timing and administration of paracetamol on postoperative shivering. |
|
Scientific Title of Study
|
Impact of intraoperative timing and administration of paracetamol on postoperative shivering : A randomised double blind controlled 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 |
Norin Qashifa |
| Designation |
MD anaesthesiology postgraduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology Critical care and pain medicine. Sri Ramachandra Institute of Higher Education and Research. Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9500341201 |
| Fax |
|
| Email |
norinqashifa@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Jayaraman V |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology Critical care and pain medicine. Sri Ramachandra Institute of Higher Education and Research. Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9841219820 |
| Fax |
|
| Email |
vjram2001@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Norin Qashifa |
| Designation |
MD anaesthesiology postgraduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology Critical care and pain medicine. Sri Ramachandra Institute of Higher Education and Research. Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9500341201 |
| Fax |
|
| Email |
norinqashifa@ymail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology,
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai- 600116 |
| 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 Norin Qashifa |
Sri Ramachandra Institute of Higher Education and Research |
6th floor, Udayar block, Department of Anaesthesiology, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116
Chennai
TAMIL NADU |
9500341201
norinqashifa@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Paracetamol |
Inj.Paracetamol 15mg/kg will be administered 30 minutes before completion of surgery. |
| Intervention |
Inj.Paracetamol |
Inj.Paracetamol 15mg/kg will be administered 15 minutes after induction of anaesthesia. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I/II adult patients of either gender undergoing elective surgical procedures performed under General Anaesthesia.
Expected duration of surgery between 1 and 4 h |
|
| ExclusionCriteria |
| Details |
Surgeries more than 4 hour duration.
Those having body mass index more than 35 kg/m2.
Evidence of liver dysfunction.
History of allergy to Paracetamol.
Body temperature more than 38°C or less than 36°C. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The incidence of shivering. |
The incidence of shivering will be assessed every 30 minutes postoperatively up to a period of 4 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The incidence of perioperative hypothermia (temperature less than 36°C) |
Core temperature will be monitored every 15 minutes after induction of anaesthesia till the completion of surgery & every 30 minutes after completion of surgery up to a period of 4 hours. |
| Time to analgesic requirement postoperatively |
Pain & time to analgesic requirement will be monitored every 30 minutes after surgery upto a period of 4 hours. |
|
|
Target Sample Size
|
Total Sample Size="255"
Sample Size from India="255"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="2"
Months="0"
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
|
Following general anesthesia, postoperative shivering is common. The mechanism may be thermogenic or non-thermogenic. During the postoperative phase, there is an increase in the set point for core body temperature, which is reached by shivering. Numerous adverse effects, including an increased risk of hypoxemia and surgical complications, may result from this. In addition to having an anti-shivering action, paracetamol can worsen intraoperative hypothermia. This study compares the incidence of shivering as the primary outcome and the incidence of perioperative hypothermia (temperature less than 36°C) and the time to the analgesic requirement as secondary outcomes when paracetamol was administered after induction of anaesthesia or towards the conclusion of surgery. |