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
|
|
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
|
|
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 |