| CTRI Number |
CTRI/2025/10/096733 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of a sedative in caesarean delivery. |
|
Scientific Title of Study
|
Effect of intravenous ketamine infusion on obstetric quality of recovery score in patient undergoing cesarean delivery after spinal anesthesia: A randomized, triple-blinded, 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 |
Soumita Biswas |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Room no. 112,Department of Anesthesiology, Neuro OT complex, Second floor, Indira Gandhi Institute Medical Sciences, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
7595911185 |
| Fax |
|
| Email |
creambells95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Room no. 113, Department of Anesthesiology, Neuro OT Complex, second floor, Indira Gandhi Institute of Medical Sciences, Patna
Patna
BIHAR
800013
India |
| Phone |
9113463130 |
| Fax |
|
| Email |
Swatipgi2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swati |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Room No. 113
Department of Anesthesiology,Neuro OT Complex
Indira Gandhi Institute of Medical Sciences, Patna
Patna
BIHAR
800013
India |
| Phone |
9113463130 |
| Fax |
|
| Email |
Swatipgi2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Science, Sheikhpura, Patna, Bihar, 800014 |
|
|
Primary Sponsor
|
| Name |
Soumita Biswas |
| Address |
Room no. 113, Neuro OT complex, Second floor, Indira Gandhi Institute of Medical Science, Patna 800013, Bihar, India |
| 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 Soumita Biswas |
Indira Gandhi Institute of Medical Science |
Room no. 113, Department of Anesthesiology, Neuro OT complex,Indira Gandhi Institute of Medical Science, Sheikhpura,800013
Patna
BIHAR |
7595911185
creambells95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Indira Gandhi Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C |
1O ml saline bolus followed by infusion |
| Intervention |
Group K |
0.3 mg/kg ketamine in 10 ml of saline bolus followed by 0.1 mg/kg/hr infusion |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
41.00 Year(s) |
| Gender |
Female |
| Details |
Female patients and full term, between 21 and 41, with ASA I, II, III, and undergoing elective cesarean section. |
|
| ExclusionCriteria |
| Details |
1) Twins and preterm birth
2) Hypertensive and pre-eclampsia patient
3) Morbidly obese patient
4) Spinal anesthesia contraindication because the patient refused, severe mitral or tricuspid stenosis and local infection |
|
|
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 |
| Effect of intravenous ketamine infusion on obstetric quality of recovery score |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters (MAP and HR) |
15 minutes, 30 minutes, 45 minutes, 60 minutes |
| Ramsay Sedation Score |
5 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes |
| VAS Score |
4 hours, 8 hours, 12 hours, 16 hours, 24 hours |
| APGAR Score |
1 minute, 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a study measuring patient centered outcome to guide meaningful changes in obstetric anesthesia care. The obstetric quality of recovery score provides a holistic measure of patient reported recovery for mother undergoing cesarean delivery, comprising both psychological and functional outcomes. In this study we have planned to determine effectiveness of low dose ketamine infusion in patient receiving spinal anesthesia for lower uterine section. Primary Objective is to compare OBS Q0R11 score in patient receiving low dose ketamine infusion vs control group at 24 hours time period point in post operative period. Secondary Objective are hemodynamic parameter, post operative pain assessed by VAS score, sedation score, fetus evaluated by APGAR score, post operative nausea, vomiting, nystagmus, diplopia and hallucination, Ramsay sedation score, perioperative shivering. Type of study is randomized, triple blind, prospective, controlled study. Inclusion criteria comprises of full term female patient between 21 and 41 with ASA I, II, III. Exclusion criteria comprises of twins and preterm birth, hypertensive and pre eclampsia patient, morbidly obese patient, spinal anesthesia contraindication because the patient refused, severe mitral and tricuspid stenosis and local infection The patient would be equally randomized into two groups. One group will be given intravenous ketamine and the other group will be given intravenous saline. OBSQ0R11 scale at 24 hours in post operative will be seen Sample size is 142.
|