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CTRI Number  CTRI/2025/08/092547 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 02/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Impact of Segmental Spinal Anesthesia on Lung Function in Laparoscopic Gallbladder Surgery: A Pilot Study 
Scientific Title of Study   Impact of Segmental Spinal Anesthesia on Pulmonary Function and Outcomes in Laparoscopic Cholecystectomy: A Randomized Controlled Pilot Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikita Choudhary 
Designation  Assistant Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anaesthesiology Level 6 Medical college Building AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9039134347  
Fax    
Email  choudhary.20nikita@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nikita Choudhary 
Designation  Assistant Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anaesthesiology Level 6 Medical college Building AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9039134347  
Fax    
Email  choudhary.20nikita@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikita Choudhary 
Designation  Assistant Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anaesthesiology Level 6 Medical college Building AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9039134347  
Fax    
Email  choudhary.20nikita@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Rishikesh Veerbhadhra road Uttarakhand 249203 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  Department of Anaesthesiology AIIMS Rishikesh Veerbhadhra road Rishikesh 249203 
Type of Sponsor  Research institution and hospital 
 
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 Nikita Choudhary  ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH  Department Of Anaesthesiology Level 6 Medical college Building
Dehradun
UTTARANCHAL 		 9039134347

choudhary.20nikita@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General Anaesthesia group  Patients will receive general anaesthesia, where patients will be anaesthetised by putting i.v. medications and inhalational anaesthetic gases. Respiration will be continued after securing the airway by means of mechanical ventilation and each vital parameter and ventilator settings will be monitored meticulously with necessary modifications from time to time as per individual patient’s need. At the end of surgery, their respiratory effort will be reversed by using specific reversal medication. Patients found unfit for immediate reversal would be shifted to intensive care setup for guided management and easy recovery 
Intervention  Segmental Thoracic Spinal anaesthesia group  Patients will receive segmental thoracic spinal anaesthesia, in the form of medications injected into the space around their spinal cord in order to achieve defined level of regional anaesthesia and they will experience some amount of drowsiness within a defined narrow range as a result of sedation but they will be spontaneously breathing on their own. In case, any patient can’t undergo this technique, they will be converted to general anaesthesia  
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  70.00 Day(s)
Gender  Both 
Details  Age 18 to 70 years

All genders

American Society of Anaesthesiology physical status I till III
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Contraindications to spinal anaesthesia (e.g., bleeding diathesis, infection)
3. Pregnancy
4.BMI more than 35
5.Severe systemic disease (ASA IV)
6.Patients having pre-existing severe respiratory illnesses (ARISCAT Score more than 44)
7. Vertebral deformity or previous spine surgeries
8. Allergy to local anaesthetics
9. Inadequate spinal anaesthesia effects
10. Intraoperative changes in surgery plan
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Peak expiratory flow rate (assessed using a hand-held spirometer)
 		 T0- preoperative
T1-6 hours post operative period

T2- 24 hours post operative period

T3-48 hours post operative period
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Breath holding time and SpO2
2. Postoperative lung aeration score (USG assessed)
3.Trans-diaphragmatic excursion (ultrasound assessed Delta TDI)
4. Other postoperative pulmonary complications (haemodynamic, pulmonary & other system)
5. Satisfaction scores of patients & surgeons
 		 Predefined time points [preoperative (T0), postoperative (T1) at 6 hr, postoperative day 1 (T2) 24 hr, postoperative day 2 (T3) 48 hr for breath holiding time and spo2 and for Trans-diaphragmatic excursion (ultrasound assessed Delta TDI)
Preoperative period (time point A), five minutes after induction (time point B), five minutes after pneumoperitoneum (time point C), at the end of surgery but before extubation (time point D), after one-hour post-extubation in the postoperative room (time point E), postoperative (T1) at 6 hr, postoperative day 1 (T2) 24 hr, postoperative day 2 (T3) 48 hr for Postoperative lung aeration score (USG assessed) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/09/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [choudhary.20nikita@gmail.com].

  6. For how long will this data be available start date provided 01-11-2025 and end date provided 01-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a prospective, randomised analyser blinded study. This study aims to explore the impact of segmental spinal anaesthesia on postoperative pulmonary function and overall patient outcomes in patients undergoing Laparoscopic cholecystectomy comparing it with general anaesthesia in randomised controlled pilot trials. The study duration is 2 years. Stratified randomization methodology will be used and after allocation patients will be divided into two groups( General anaesthesia and segmental spinal anaesthesia). The primary objective of this study is to compare the peak expiratory flow rate at predefined time points [ preoperative (T0), postoperative (T1) at  6 hr, postoperative day 1(T2), 24 hr postoperative day 2(T3) 48 hr in patients receiving general anaesthesia versus segmental spinal anaesthesia for laparoscopic cholecystectomy surgery. Secondary objectives are to compare other parameters for pulmonaryoutcome analysis at predefined time points , to compare the USG parameters for pulmonary function assessment during perioperative period at predefined time points,  to compare evidence of any other perioperative complication and to compare the satisfaction scores of patients and surgeons in patients undergoing laparoscopic cholecystectomy.  
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