| CTRI Number |
CTRI/2026/01/101571 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Number of laparoscopic gynaecological surgeries induced under spinal that get converted to general anesthesia or need intravenous sedation |
|
Scientific Title of Study
|
Incidence of conversion to general anesthesia and need for intravenous supplementation in patients undergoing gynecologic laparoscopic procedures under spinal anesthesia: an observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Ganesh Pai |
| Designation |
Post graduate |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Postgraduate Department of Anaesthesiology
Karnataka Institute of Medical Sciences
Vidyanagar, Hubli, Dharwad
Dharwad KARNATAKA 580022 India |
| Phone |
9108558519 |
| Fax |
|
| Email |
pai.swatiganesh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashwini H R |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Associate Professor Department of Anaesthesiology
Karnataka Institute of Medical Sciences
Vidyanagar, Hubli, Dharwad
Dharwad KARNATAKA 580022 India |
| Phone |
9480553670 |
| Fax |
|
| Email |
ashvenki.hubli@gamil.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashwini H R |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Associate Professor Department of Anaesthesiology
Karnataka Institute of Medical Sciences
Vidyanagar, Hubli, Dharwad
Dharwad KARNATAKA 580022 India |
| Phone |
9480553670 |
| Fax |
|
| Email |
ashvenki.hubli@gamil.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Swati Ganesh Pai |
| Address |
Postgraduate Department of Anaesthesiology
Karnataka Institue of Medical Sciences
Vidyanagar, Hubli, Dharwad
Karnataka- 580022 |
| 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 Swati Ganesh Pai |
Karnataka Institute of Medical Sciences |
Department of Anaesthesiology
Room Number 206, Karnataka Institute of Medical Sciences
Hubli Dharwad KARNATAKA |
9108558519
pai.swatiganesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe, KIMS HUBLI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA physical status class 1 and 2
posted for gynaecological laparoscopic procedures under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
refusal to spinal anaesthesia
ASA physical status class 3 and 4
allergic to local anaesthetics
coagulation disorders
infection at lumbar puncture site
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of conversion from Spinal anaesthesia to GA in gynaecologic laparoscopic surgeries when spinal anaesthesia is provided. |
assess when the patient complains of pain or discomfort and a need to convert to general anaesthesia and iv supplementaion in needed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the rate of intraoperative intravenous supplementation, drugs administered and the time of administration. |
noted when case converted to general anaesthesia or iv supplementation in given |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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)
|
30/01/2026 |
| 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="3" 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
|
Laparoscopic procedures, increasingly used in gynaecology, have traditionally been performed under general anaesthesia (GA). However, with the growth of day-care surgeries, spinal anaesthesia (SA) is being used more widely due to advantages such as rapid recovery, reduced postoperative pain, minimal respiratory compromise, and better haemodynamic stability. Despite these benefits, SA may be associated with complications including shoulder pain, inadequate analgesia, nausea, vomiting, and hypotension. Failed or inadequate spinal blocks may lead to intraoperative intravenous supplementation or conversion to GA, which carries a higher risk of complications compared to either technique alone. This prospective observational study aims to determine the incidence and reasons for conversion from SA to GA in elective gynaecological laparoscopic surgeries. A total of 180 ASA I–II female patients aged 18–60 years undergoing procedures at KIMS, Hubli will be evaluated. Standard preoperative preparation and spinal anaesthesia with 0.5% hyperbaric bupivacaine will be administered. Intraoperative parameters, requirement for intravenous supplementation, timing of drug administration, complications, and factors such as anaesthesiologist and surgeon experience will be recorded. Data will be analysed using appropriate statistical tests and multivariable regression to identify predictors of conversion. The study aims to improve understanding of SA reliability and factors influencing its failure in gynaecologic laparoscopy. |