| CTRI Number |
CTRI/2025/09/094745 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of 2 drugs Dexmedetomidine and Nefopam For Treatment Of Intraoperative Shivering in Adult Patients Undergoing Surgery Under Anesthesia |
|
Scientific Title of Study
|
Thermoregulatory Challenges In The Operating Room: Dexmedetomidine Versus Nefopam In The Management Of Intraoperative Shivering- A Comparative Study |
| 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 Ambati Santosha Lakshmi |
| Designation |
Assistant Professor |
| Affiliation |
Gitam Institute Of Medical Sciences And Research |
| Address |
Gitam Institute Of Medical Sciences And Research,
Department Of Anaesthesiology
Rushikonda,
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9440532547 |
| Fax |
|
| Email |
sambati2@gitam.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambati Santosha Lakshmi |
| Designation |
Assistant Professor |
| Affiliation |
Gitam Institute Of Medical Sciences And Research |
| Address |
Gitam Institute Of Medical Sciences And Research,
Department of Anaesthesiology,
Rushikonda,
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9440532547 |
| Fax |
|
| Email |
sambati2@gitam.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ambati Santosha Lakshmi |
| Designation |
Assistant Professor |
| Affiliation |
Gitam Institute Of Medical Sciences And Research |
| Address |
Gitam Institute Of Medical Sciences And Research,
Department Of Anaesthesiology,
Rushikonda,
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9440532547 |
| Fax |
|
| Email |
sambati2@gitam.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ambati Santosha Lakshmi |
| Address |
Gitam Institute Of Medical Sciences, 5 168, Ward NO 6, GF Gitam University Rushikonda, Visakhapatnam, Andhra Pradesh 530045 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ambati Santosha Lakshmi |
Gitam Institute Of Medical Sciences And Research |
Department Of Anaesthesiology,
Third Floor, Rushikonda, Visakhapatnam, Andhra Pradesh 530045
Visakhapatnam
ANDHRA PRADESH |
9440532547
sambati2@gitam.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gitam Institute Of Medical Sciences |
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 |
Dexmedetomidine |
Both Drugs Are Used For Control Of Intraoperative Shivering.
This Study Aims To Compare The Thermoregulatory Effects, Efficacy And Safety Profile Of Both Drugs In Controlling Intraoperative Shivering
Dose- 1mcg/kg IV |
| Comparator Agent |
Nefopam |
Both Drugs Are Used For Control Of Intraoperative Shivering.
This Study Aims To Compare The Thermoregulatory Effects, Efficacy And Safety Profile Of Both Drugs In Controlling Intraoperative Shivering
Dose- 0.15mg/kg IV |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients Undergoing Elective Surgeries Under Regional Anaesthesia. |
|
| ExclusionCriteria |
| Details |
Known Hypersensitivity To Study Drugs
Severe Cardiovascular, Respiratory, Renal, Hepatic And Neurological Diseases.
Patients With A Contraindication To Regional Anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nefopam is better as compared to dexmedetomidine for control of intraoperative shivering under spinal anesthesia due to its rapid onset, higher response rate, no sedation, lesser hemodynamic alterations, lesser requirements of rescue analgesics & lesser costs. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nefopam is better as compared to dexmedetomidine for control of intraoperative shivering under spinal anesthesia due to its rapid onset, higher response rate, no sedation, lesser hemodynamic alterations, lesser requirements of rescue analgesics & lesser costs. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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="3"
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
|
Intraoperative shivering is a frequent complication observed during surgeries performed under regional anesthesia. It can interfere with monitoring, increase oxygen consumption, elevate cardiac workload, and cause significant patient discomfort. Effective and timely management of shivering during surgery is therefore essential for patient safety and comfort.Dexmedetomidine, a selective Alpha 2-adrenergic agonist, has been shown to possess anti-shivering properties through central thermoregulatory modulation and mild sedative effects. Nefopam, a non-opioid, centrally acting analgesic, also has anti-shivering effects by inhibiting the reuptake of serotonin, norepinephrine, and dopamine. Both agents are known to be effective individually, but comparative data on their efficacy and safety for intraoperative shivering are limited.This randomized, double-blind, controlled clinical trial is designed to compare the efficacy and safety of intravenous dexmedetomidine and nefopam for the control of intraoperative shivering in adult patients undergoing elective surgeries. The primary objective is to assess which drug is more effective in controlling shivering during surgery with minimal adverse effects. Secondary objectives include evaluation of sedation levels, hemodynamic stability, and incidence of drug-related side effects. This study aims to generate clinical evidence that can guide anesthesiologists in choosing the most appropriate pharmacologic agent for managing intraoperative shivering.
|