| CTRI Number |
CTRI/2025/03/081935 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Spinal Anesthesia versus General Anesthesia in Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
Comparative study between Segmental spinal block versus General Anesthesia on fitness for patient discharge post operatively in patients undergoing Laparoscopic Cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saborni Ganguly |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department OF Anesthesiology,
Institute of Medical Sciences,
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8777854171 |
| Fax |
|
| Email |
gangulysaborni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AP Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department OF Anesthesiology,
Institute of Medical Sciences,
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839412975 |
| Fax |
|
| Email |
bhuapsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AP Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department OF Anesthesiology,
Institute of Medical Sciences,
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839412975 |
| Fax |
|
| Email |
bhuapsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences,
Banaras Hindu University, Varanasi 221005, India. |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences |
| Address |
Banaras Hindu University, Varanasi 221005, India. |
| 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 AP Singh |
Sir Sunderlal Hospital,Institute of Medical Sciences, Banaras Hindu University |
Department of Surgery and Department of Anesthesiology, Institute of Medical Sciences,
Banaras Hindu University, Varanasi 221005
Varanasi
UTTAR PRADESH |
9839412975
bhuapsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A |
Group A will undergo Laparoscopy cholecystectomy under general anesthesia. They will be premedicated with Inj Midazolam and induced with Inj Fentanyl,Inj Propofol and Inj Vecuronium followed by Igel insertion. Maintainance will be achieved by Isoflurane, increments of muscle relaxant and controlled mechanical ventilation. EtCO2 will be maintained at 35-40 mm Hg. Lastly residual neuromuscular blockade will be antagonized with Neostigmine and Glycopyrrolate combination. |
| Comparator Agent |
GROUP B |
Group B will undergo Laparoscopy cholecystectomy under segmental spinal anesthesia. Under aseptic precautions 25G Quinkies needle will be introduced in T10-T11 space in sitting position and after confirming free CSF flow 7.5mg isobaric Levo Bupivacaine 0.5% and 15mcg Fentanyl will be injected. Inj Ketamine 0.5mg/kg will be given before gas insufflation to prevent shoulder tip pain. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective laparoscopic cholecystectomy of duration less than 90minutes with uncomplicated gallstone disease of either gender in the age group 30-45,with ASA grade I & II |
|
| ExclusionCriteria |
| Details |
Patient refusal for participating in the study.
ASA Grade III and IV patients.
Patients with active cholecystitis.
Patients with coagulopathy.
Patients with BMI more than 32 kg per m2.
Spinal deformity or previous spine surgery.
Any other contraindication to central neuraxial blockade or thoracicsegmental spinal anesthesia.
Patients allergic to the study drugs.
Requiring more than 3 attempts for the procedure |
|
|
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 |
| Comparison of time to unaided mobility post operatively in patients undergoing laparoscopic cholecystectomy in segmental spinal block versus general anesthesia. |
assessed every 30minutes post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of post operative nausea and vomiting in both groups.
Timing of acceptance of clear fluids & return of bowel movements .
Post operative pain by visual analogue scale
Time at which patient passed urine post operatively
Time to discharge |
postoperative nausea and vomiting-24 hours post operatively
Post operative pain after 2hour 4 hour 8 hour 12hour 24hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/04/2025 |
| 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="9"
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
|
Written informed consent will be obtained from each lot for anesthesia technique and probabilty to convert to general anesthesia if needed Group A will undergo Laparoscopic cholecystectomy under general anesthesia and Group B under segmental spinal block
Time to go test will be assessed three hours after completion of surgery i.e whether patients will be able to walk without support for 45 meters and then return to the starting point.Patients will be allowed to leave the hospital once they had passed urine and had been assessed by the surgeon. Comparison of time to unaided mobility will be assessed every 30minutes post operatively Incidence of post operative nausea and vomiting in both groups,timing of acceptance of clear fluids & return of bowel movements,post operative pain by visual analogue scale,time at which patient passed urine post operatively,time to discharge will all be assessed thereafter. |