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CTRI Number  CTRI/2015/04/005715 [Registered on: 24/04/2015] Trial Registered Retrospectively
Last Modified On: 18/03/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Is spinal anaesthesia more safe and effective than general anaesthesia for open surgery of gall bladder? 
Scientific Title of Study   A comparative study on safety and effectiveness of spinal anaesthesia versus general anaesthesia for open cholecystectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ram Bhakta Koju 
Designation  Associate Professor and Head 
Affiliation  KIST Medical College 
Address  Department of Anesthesiology and Critical Care
KIST Medical College, Imadol, Lalitpur, Nepal


44600
Other 
Phone  977-9841113271  
Fax  977-1-5201496  
Email  dr.koju@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ram Bhakta Koju 
Designation  Associate Professor and Head 
Affiliation  KIST Medical College 
Address  Department of Anesthesiology and Critical Care
KIST Medical College, Imadol, Lalitpur, Nepal


44600
Other 
Phone  977-9841113271  
Fax  977-1-5201496  
Email  dr.koju@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ram Bhakta Koju 
Designation  Associate Professor and Head 
Affiliation  KIST Medical College 
Address  Department of Anesthesiology and Critical Care
KIST Medical College, Imadol, Lalitpur, Nepal


44600
Other 
Phone  977-9841113271  
Fax  977-1-5201496  
Email  dr.koju@gmail.com  
 
Source of Monetary or Material Support  
Principal investigator self funded study with the infrastructure and other logistic support from the Korea Nepal Friendship Hospital 
 
Primary Sponsor  
Name  Dr Ram Bhakta Koju 
Address  Department of Anesthesiology and Critical Care, Korea Nepal Friendship Hospita (Off Hour) and KIST Medical College (Full Time), Lalitpur, Nepal. 
Type of Sponsor  Other [[Principal Investigator]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Nepal  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ram Bhakta koju  Korea Nepal Friendship Hospital  Department of Anesthesia and Critical Care, Korea Nepal Friendship Hospital, Thimi, Bhaktapur, Nepal

 
977-9841113271
977-1-5201496
dr.koju@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hospital Authority  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Uncomplicated symptomatic gallstone disease with ASA I or II physical status, aged between 18 and 70 years of either sex, and BMI ≤ 30 kg/m2 ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General anesthesia  General anesthesia is used as an anesthetic technique 
Intervention  Spinal anesthesia  Spinal anesthesia is used as an anesthetic technique. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with uncomplicated symptomatic gallstone disease undergoing open cholecystectomy and complying with ASA I or II physical status, aged between 18 and 70 years of either sex, and BMI ≤ 30 kg/m2.  
 
ExclusionCriteria 
Details  Pancreatitis, contraindication of SA, hypersensitivity to bupivacaine and pethedine and severe cardiopulmonary disease for both SA and GA group. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Pain-free interval post-surgery  1, 2, 4, 8, 12, 16, 24 and 48 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1) Hemodynamic instability
2) Post operative nausea and vomiting
3)Respiratory problems
4)Analgesic required to manage pain
5)Post-dural puncture headache
 
1, 2, 4, 8, 12, 16, 24 and 48 hours after surgery 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/08/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   Yet to submit. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Background: Cholecystectomy is performed either as open or laparascopic cholecystectomy. Despite of a number of peri-operative and post-operative benefits of laparascopic cholecystectomy, the older and more invasive open cholecystectomy is still in frequent practice for various reasons. Though general anaesthesia is regarded as the gold standard anaesthetic technique, alternatives to it such as spinal anaesthesia, with its advantages, outweighs general anaesthesia. Spinal anaesthesia, therefore, could be a safe and effective anaesthetic procedure over general anaesthesia for open cholecystectomy.

 

Methods: After the approval from the hospital ethical committee and written consent received from the patients, 120 patients with uncomplicated symptomatic gallstone disease undergoing open cholecystectomy and complying with ASA I or II physical status, aged between 18 and 70 years of either sex, and BMI ≤ 30 kg/m2 were enrolled for the study. They were randomly categorized into SA group (received spinal anaesthesia) and GA group (received general anaesthesia), each group containing 60 patients. Intra-operative events and post-operative events were observed up to 48 hours post-surgery and compared between the groups. Data are represented in percentage, mean with standard deviation and median. Statistical analysis was done using independent t-test and Mann-Whiteney U test.

 

Results: Spinal anaesthesia is safe and effective in pain management post open cholecystectomy. The pain-free interval in SA group was 4 hours as compared to 30 minutes in GA group. Majority (90%) in SA groups were managed with intramuscular diclofenac whereas majority in GA group were managed with intravenous pethedine. Intra-operatively, SA group had more cases of haemodynamic instability than GA group, which were easily managed in both the groups. The differences in the incidence of post-operative nausea and vomiting and the days of hospital stay between the groups were not significant.

 

Conclusion: Spinal anaesthesia is safe and more effective than general anaesthesia for uncomplicated open cholecystectomy in terms of peri-operative events, in reducing post-operative pain, and in terms of surgeon’s satisfaction as well.


Keywords: Cholelithiasis, General anaesthesia, Open cholecystectomy, Pain, Spinal anaesthesia 
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