| CTRI Number |
CTRI/2024/02/062572 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Thoracic segmental spinal anaesthesia and standard general anaesthesia are compared in patients posted for open cholecystectomy |
|
Scientific Title of Study
|
Comparison of thoracic segmental spinal anaesthesia with standard general anaesthesia in open cholecystectomy: A Parallel Arm Randomized Clinical 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 |
Shuchi Nigam |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai |
| Address |
Room number 332
Department of Anaesthesia
Uttar Pradesh University of Medical Sciences
Etawah
UTTAR PRADESH
206130
India |
| Phone |
07017954040 |
| Fax |
|
| Email |
shuchinigam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shuchi Nigam |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai |
| Address |
Room number 332
Department of Anaesthesia
Uttar Pradesh University of Medical Sciences
UTTAR PRADESH
206130
India |
| Phone |
07017954040 |
| Fax |
|
| Email |
shuchinigam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shuchi Nigam |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai |
| Address |
Room number 332
Department of Anaesthesia
Uttar Pradesh University of Medical Sciences
UTTAR PRADESH
206130
India |
| Phone |
07017954040 |
| Fax |
|
| Email |
shuchinigam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences |
| Address |
Room number 332
Department of Anaesthesia
Uttar Pradesh University of Medical Sciences |
| 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 Shuchi Nigam |
Uttar Pradesh University of Medical Sciences, Saifai |
Room number 332
Department of Anaesthesia
UPUMS, Saifai
Etawah
UTTAR PRADESH |
07017954040
shuchinigam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Uttar Pradesh University of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General Anaesthesia |
all patients will be pre medicated with injection fentanyl (2 µg/ kg body weight) + injection glycopyrrolate (5 µg/ kg body weight). Preoxygenation will be done with 100% O2 for 3 minutes, patients will be induced with injection Propofol (2-3mg/kg iv). The laryngoscopy and intubation will be facilitated with injection Vecuronium (0.1 mg/kg I.V). Intraoperative anaesthesia and muscle relaxation will be maintained with N2O, O2, Isoflurane using controlled ventilation. |
| Intervention |
Thoracic Segmental Spinal Anaesthesia |
Patients will receive Thoracic Segmental Spinal Anaesthesia at a level of T7-T8 intervertebral space with 0.75% isobaric Ropivacaine in a dose of 1ml + 20µg of fentanyl |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I and II
2. Patients with body mass index between 18-30.
3. Patients undergoing open cholecystectomy |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Any contraindication to spinal anaesthesia
3. Patient having allergy with any of the drugs used in the study.
5. Patients with physical or mental problems leading to inability to comprehend scoring system to be employed.
6. Opioid tolerance or dependence.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters |
5, 10, 15, 30, 45 and 60min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction measured by 5-point Likert scale. |
after 6hrs of surgery. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/02/2024 |
| Date of Study Completion (India) |
31/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shuchinigam@gmail.com].
- For how long will this data be available start date provided 01-07-2024 and end date provided 30-06-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
Regional anesthesia is considered a favorable modality with significant potential in selected patients and is becoming more popular day by day . Regional anesthesia techniques can attenuate surgical stress response and provide better analgesia with reduction in postoperative opioid consumption.This study aims to compare Thoracic Segmental Spinal Anaesthesia and Spinal Anaesthesia in patients undergoing open Cholecystectomy.
The patients will be divided into 2 groups of 23 each. Group A: Patients who will receive Thoracic Segmental Spinal Anaesthesia with 0.75% isobaric Ropivacaine in a dose of 1ml + 20µg of fentanyl Group B: Patients who receive Standard General Anaesthesia
|