| CTRI Number |
CTRI/2024/03/064924 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The Effect Of Dexmedetomidine And Butorphanol After Spinal Anaesthesia Shivering |
|
Scientific Title of Study
|
Comparative Study Of The Effect Of Dexmedetomidine And Butorphanol On Post-Spinal Anesthesia Shivering |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanju Prajapati |
| Designation |
PG Student |
| Affiliation |
Pandit Deendayal Upadhyay Medical College, Rajkot |
| Address |
Department of anesthesiology,3rd floor OPD building, Pandit Deendayal Upadhyay Medical College, Rajkot
Rajkot
GUJARAT
360001
India |
| Phone |
9979020823 |
| Fax |
|
| Email |
sanjuprajapati67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanju Prajapati |
| Designation |
PG Student |
| Affiliation |
Pandit Deendayal Upadhyay Medical College, Rajkot |
| Address |
Department of anesthesiology,3rd floor OPD building, Pandit Deendayal Upadhyay Medical College, Rajkot
Rajkot
GUJARAT
360001
India |
| Phone |
9979020823 |
| Fax |
|
| Email |
sanjuprajapati67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urmi Dave |
| Designation |
Assistant Professor In Anesthesiology |
| Affiliation |
Pandit Deendayal Upadhyay Medical College, Rajkot |
| Address |
Department of anesthesiology,3rd floor OPD building,Pandit Deendayal Upadhyay Medical College, Rajkot
Rajkot
GUJARAT
360001
India |
| Phone |
9824390609 |
| Fax |
|
| Email |
urmidave@icloud.com |
|
|
Source of Monetary or Material Support
|
| Pandit Deendayal Upadhyay Medical College, Rajkot,Gujarat 360001 |
|
|
Primary Sponsor
|
| Name |
Pandit Deendayal Upadhyay Medical College Rajkot |
| Address |
Department of anesthesiology,3rd floor OPD building,Pandit Deendayal Upadhyay Medical College, Rajkot,Gujarat 360001 |
| Type of Sponsor |
Government medical college |
|
|
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 Sanju Prajapati |
Pandit Deendayal Upadhyay Medical College, Rajkot |
Department of anesthesiology,3rd floor OPD building,Pandit Deendayal Upadhyay Medical College, Rajkot
Rajkot
GUJARAT |
9979020823
sanjuprajapati67@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE (HUMAN) PDU MEDICAL COLLEGE RAJKOT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, (2) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BUTORPHENOL |
ON POST SPINAL ANAESTHESIA SHIVERING
dose 0.01mg/kg diluted in 10ml normal saline ,given slowly over 10 min intravenously |
| Intervention |
DEXMEDETOMIDINE |
Dose 0.5mcg/kg diluted in 10ml normal saline,given slowly over 10 min intravenously
Dexmedetomidine acts by blocking alpha 2 receptors at locus ceruleus of brainstem and
spinal cord thus causing sedation and analgesia. Apart from sedative and analgesic effect,
Dexmedetomidine is proposed to have additional effects like it reduces the shivering
threshold and can be used to control shivering |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I, II, III |
|
| ExclusionCriteria |
| Details |
1. Refusal of patients
2. Patients with an initial body (core) temperature more than 38 degree celsius or less than 36 degree Celsius.
3. Patients with relative and absolute contraindication to spinal anesthesia
4. Allergic to any study drug
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare efficacy of intravenous dexmedetomidine and buterphenol for control of shivering after spinal anaesthesia |
Assess Shivering score from Grade 1(No shivering) to Grade 4(Severe shivering) at 1min,2min,3min,4min,5min,6min,
7min,8min,9min,10minute
Ramsay sedation score at 1min,2min,3min,4min,5min,10min,
15min,30min,60 minute
Hemodynamic changes 1min,2min,3min,4min,5min,10min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sedation score
Hemodynamic changes(HR,BP,SPO2,RR)
|
Ramsay sedation score at 1min,2min,3min,4min,5min,10min,
15min,30min,60 minute
Hemodynamic changes 1min,2min,3min,4min,5min,10min,15min,30min,60 minute
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| 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="1"
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
|
AIM: To evaluate and compare the efficacy of intravenous Dexmedetomidine and Butorphanol for control of shivering afterspinal anesthesia. As control of perioperative shivering is of paramount importance and there are very few studies available on literature search comparing anti-shivering efficacy of Dexmedetomidine and Butorphanol in control of post-anesthetic shivering that’s why we decided to do this comparative study. GRADE I: No shivering observed. GRADE II: Mild Shivering, slight facial and cervical muscle contraction GRADE III: Moderate Shivering, obvious shivering in the head and neck, shoulders and /or extremities GRADE IV: Severe Shivering, obvious shaking all over the body. Only supplemental oxygen will be given to patients who develops shivering of GRADE I, at the rate of 5L/Min with face mask. Patients will be covers with drapes but not actively warmed. Patients who develops either GRADE II to IV shivering included in study. These patients apart from supplemental oxygen and covering with drapes, will be randomly administered either inj. Dexmedetomidine 0.5mcg / kg diluted in 10 ml Normal Saline given IV slowly over 10 minutes or, inj. Butorphanol 0.01mg / Kg diluted in 10 ml Normal Saline given slowly over 10 min. Time taken for cessation of shivering, recurrence of shivering, hemodynamic status and sedation scores are observed from 1 min to 5 min and then 10min ,20min,30min and 60 min . Shivering control is defined as: Complete :when shivering score declines to 0, Incomplete: when the scores decreases but did not abolish the shivering completely Failed: if no change in scores observes. Episodes of recurrence or incomplete control will be treated with active warming measures such as warmer (body warmer and fluid warmer), or multimodal therapy Inj. Ketamine 0.5mg/kg IV and/or Inj.Dexona 8mg IV.
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