| CTRI Number |
CTRI/2024/09/074401 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the effect of early versus late
paracetamol administration on postoperative
shivering |
|
Scientific Title of Study
|
To evaluate the effect of early versus late
paracetamol administration on postoperative
shivering and pain scores after general
anaesthesia- A prospective randomized double
blind clinical 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 Shiny Sharon |
| Designation |
Post graduate student- MD Anaesthesiology |
| Affiliation |
AIl India Institute of Medical Sciences, Rajkot, Gujarat |
| Address |
Room no.207,Old OPD building Department of
Anaesthesiology, AIIMS hospital,Khanderi village, Para pipaliya, Rajkot, Gujarat
Rajkot
GUJARAT
360006
India |
| Phone |
9949092025 |
| Fax |
|
| Email |
shiny9446@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kriti Chaudhary |
| Designation |
Associate Professor, Dept. of Anaesthesiology, AIIMS Rajkot |
| Affiliation |
AIl India Institute of Medical Sciences, Rajkot, Gujarat |
| Address |
Dept. of Anaesthesiology,
AIIMS Rajkot
Khanderi, Para pipaliya, Rajkot, Gujarat
Pin code-360006
Rajkot
GUJARAT
360006
India |
| Phone |
9785036006 |
| Fax |
|
| Email |
kritisms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kriti Chaudhary |
| Designation |
Associate Professor, Dept. of Anaesthesiology, AIIMS Rajkot |
| Affiliation |
AIl India Institute of Medical Sciences, Rajkot, Gujarat |
| Address |
Dept. of Anaesthesiology,
AIIMS Rajkot
Khanderi, Para pipaliya, Rajkot, Gujarat
Pin code-360006
Rajkot
GUJARAT
360006
India |
| Phone |
9785036006 |
| Fax |
|
| Email |
kritisms@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rajkot,Pin code-360006, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Dr Shiny Sharon |
| Address |
AIIMS hospital Rajkot,Khanderi village, Para pipaliya, Rajkot, Gujarat
Pin code-360006 |
| Type of Sponsor |
Other [Central government institute] |
|
|
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 Shiny Sharon |
AIIMS Hospital,Rajkot |
Room no.207,old OPD building,Department of Anaesthesiology, AIIMS Hospital, Rajkot,khanderi village,Parapipaliya, pin code-360006,Gujarat
Rajkot
GUJARAT |
9949092025
shiny9446@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,AIIMS Rajkot |
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 |
Early Paracetamol group |
IV PCM 15 mg/kg (maximum 1 g) over 20 min immediately after anaesthesia induction |
| Intervention |
Late Paracetamol group |
IV PCM 15 mg/kg (maximum 1 g) for 20 min approximately 30 min before completion of surgery |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients scheduled for elective surgery under general anesthesia
2.Age 18-65 years
3.Either gender
4.American Society of Anaesthesiologists (ASA) physical status classification system I/II 5.Expected duration of surgery 1- 4 h. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.BMI more than 40 kg/cm2
3. Known allergy to paracetamol or contraindications to its use
4.Pre-operative and intraoperative body temperature more than 38°C or less than 36°C
5.Patients having history of seizures, thyroid or hepatic disorder. |
|
|
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 |
| To compare the proportion of patients developing postoperative shivering till 4 hours postoperatively after intraoperative administration of early and late paracetamol. |
Just after shifting patient to post-anaesthesia care unit, then at every 30 mins till 4 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare the severity of shivering in patients developing POS.
2. To observe the pain scores and time to analgesic requirement in the postoperative period
with early and late PCM administration while minimizing the effect of intraoperative
opioids on postoperative pain scores.
3. To compare the proportion of patients developing postoperative hypothermia after early
and late PCM administration while maintaining intraoperative normothermia. |
Just after shifting patient to post-anaesthesia care unit, then at every 30 mins till 4 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
12/10/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) - Published data will be available as per publication journal guidelines
- For what types of analyses will this data be available?
Response (Others) - For further research
- By what mechanism will data be made available?
Response (Others) - Published data will be available as per publication journal guidelines
- For how long will this data be available start date provided 01-07-2026 and end date provided 31-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - None
|
|
Brief Summary
|
This is a double blind randomized controlled study to evaluate the effect of early and late paracetamol administration on postoperative shivering (POS) and pain scores.A total of 174 patients will be studied. Eligible participants will be randomly allocated to one of the two groups: 1. Early PCM group- who will receive IV PCM 15 mg/kg (maximum 1 g) over 20 min immediately after anaesthesia induction. 2. Late PCM group- who will receive IV PCM 15 mg/kg (maximum 1 g) for 20 min approximately 30 min before completion of surgery. The primary outcome will be to compare the proportion of patients developing POS till 4 hours postoperatively after intraoperative administration of early and late paracetamol.The secondary outcomes are 1. To assess and compare the severity of shivering in patients developing POS. 2. To observe the pain scores and time to analgesic requirement in the postoperative period with early and late PCM administration while minimizing the effect of intraoperative opioids on postoperative pain scores. 3. To compare the proportion of patients developing postoperative hypothermia after early and late PCM administration while maintaining intraoperative normothermia. |