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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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