| CTRI Number |
CTRI/2024/12/078790 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| 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
|
To see difference in temperature with two spinal drugs morphine and fentanyl in pregnant women undergoing cesarean section |
|
Scientific Title of Study
|
Comparison of perioperative hypothermia with intrathecal morphine (ITM) vs intrathecal fentanyl (ITF)in parturients planned for caesarean section under spinal anaesthesia |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garinepally Surya Deep |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia, Block A,4th floor,Nehru hospital,Postgraduate Institute of Medical Education and Research,Sector12,Chandigarh,
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
08309236706 |
| Fax |
|
| Email |
ssuryadeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prerna Varma |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room number:24,2nd level, Nehru hospital,Postgraduate Institute of Medical Education and Research,Sector12,Chandigarh,
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9654238627 |
| Fax |
|
| Email |
prerna.varma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prerna Varma |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room number:24,2nd level, Nehru hospital,Postgraduate Institute of Medical Education and Research,Sector12,Chandigarh,
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9654238627 |
| Fax |
|
| Email |
prerna.varma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education
and Research,Sector 12,Madhyamarg, Chandigarh,160012,India |
|
|
Primary Sponsor
|
| Name |
Director of Postgraduate Institute of Medical Education and Research |
| Address |
Postgraduate Institute of Medical Education
and Research, Sector 12,Madhyamarg,Chandigarh,160012 |
| 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 Garinepally Surya Deep |
Post Graduate Institute of Medical Education and Research |
Department of Obstetrics and Gynaecology,Nehru Hospital,PGIMER,sector 12 Chandigarh,160012
Chandigarh
CHANDIGARH |
08309236706
ssuryadeep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal Fentanyl |
Single shot hyperbaric Bupivacaine of 1.6ml of 0.5% (8 mg) along with 20 mcg fentanyl will be given intrathecally. |
| Intervention |
Intrathecal Morphine |
Single shot hyperbaric Bupivacaine of 1.6ml of 0.5% (8 mg) along with 150 mcg morphine will be given intrathecally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Parturients planned for elective caesarean section under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1.ASA Status ≥ 3
2.Refusal to take part in study.
3.Core temperature less than 36.0 â°C degrees in the preoperative assessment.
4.Contraindications for spinal anaesthesia (any bleeding disorder or coagulation abnormality).
5.Patients with any allergy to study medication (Morphine, Fentanyl, Bupivacaine).
6.Patient taking medications which impact thermoregulation (vasodilators, Antipsychotics).
7.Twin pregnancy.
8.Conversion of spinal anaesthesia to GA.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of hypothermia in the two groups |
0,15,30,45,60,75,90,105,120 minutes of spinal anesthesia
0,30,60,90,120 min post surgery
3,4,5,6,7,8,9,10,11,12 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of shivering
2. Duration of maximum temperature fall following intrathecal morphine and intrathecal fentanyl
3. Total duration of hypothermia
4. Incidence of respiratory depression, pruritus, PONV, urinary retention |
Post spinal anesthesia till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
10/01/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Neuraxial anaesthesia is a proven, rapid and common anaesthetic technique for caesarean delivery (CD). It is safe, inexpensive, easy to perform with low failure rates, and has low LAST rates. The technique has benefits of an awake mother at delivery with high maternal satisfaction rates and prevents aspiration pneumonia. intrathecal opioids are used as an adjuvant to improv ethe quality of analgesia and anaesthesia for the procedure. Intrathecal opioids may also contribute to the hypothermia due to the cephalad movement of the drug. Engorgement of the epidural veins and increased lumbar lordosis during pregnancy may have enhanced the cephalad migration of the opioids placed in the CSF. fentanyl and morphine are two such opioids commonly used as an adjuvant to spinal anaesthesia. The effect of both these drugs on the temperature of the patient has discussed as anecdotal reports in literature. Therefore, the present study has been designed to study the effect of intrathecal morphine as compared to intrathecal fentanyl on the core temperature with its associated symptoms. |