| CTRI Number |
CTRI/2024/07/071368 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of General anaesthesia vs Segmental spinal anaesthesia for Laparoscopic Appendicectomy |
|
Scientific Title of Study
|
Comparison of efficacy of Thoracic segmental spinal anaesthesia and General anaesthesia for patients undergoing Laparoscopic Appendicectomy |
| 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 Mahir Kureshi |
| Designation |
MD Anaesthesia resident |
| Affiliation |
GMERS Medical college, Gandhinagar |
| Address |
Department of Anaesthesiology, Civil hospital, Sector 12, Gandhinagar, Gujarat
Gandhinagar
GUJARAT
382016
India |
| Phone |
09737331701 |
| Fax |
|
| Email |
mahirkureshik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hina Gadani |
| Designation |
Associate Professor |
| Affiliation |
GMERS Medical college, Gandhinagar |
| Address |
Department of Anaesthesiology, Civil hospital campus, Sector 12, Gandhinagar, Gujarat
Gandhinagar
GUJARAT
382016
India |
| Phone |
8690501339 |
| Fax |
|
| Email |
hinagadani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hina Gadani |
| Designation |
MD Anaesthesia resident |
| Affiliation |
GMERS Medical college, Gandhinagar |
| Address |
Department of Anaesthesiology, Civil hospital, Sector 12, Gandhinagar, Gujarat
Gandhinagar
GUJARAT
382016
India |
| Phone |
8690501339 |
| Fax |
|
| Email |
hinagadani@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical college Gandhinagar, Gujarat, India. Pincode- 382016 |
|
|
Primary Sponsor
|
| Name |
GMERS Medical College Gandhinagar |
| Address |
GMERS Medical college, Sector 12, Gandhinagar, 382016 |
| Type of Sponsor |
Government medical college |
|
|
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 Mahir Kureshi |
GMERS MEDICAL COLLEGE GANDHINAGAR |
Surgery Operation Theatre, Civil hospital, Sector 12, Gandhinagar, 382016
Gandhinagar
GUJARAT |
09737331701
mahirkureshik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMERS Medical college, Gandhinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K37||Unspecified appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General anaesthesia |
The patients will be pre-oxygenated with 100% oxygen for 5 mins with CPAP
5-8 cm H2O.
Patients Will be induced with iv Propofol 2.5 mg/kg, fentanyl 2 μg/kg and
succinyl chlorine 1.5 mg/kg, and intubated with a suitable-sized cuffed
endotracheal tube. Anaesthesia will be maintained using Desflurane
and 50% nitrous oxide in Oxygen and Inj. Atracurium besylate (0.5 mg/kg) for
neuromuscular blocking. Ventilation will be controlled with a tidal volume of 6-
8 ml/kg, and the ventilatory rate will be adjusted to maintain a PaCO2 value of
35-40 mmHg. At the end of the surgery, the residual neuromuscular
block will be reversed by Inj. Neostigmine 0.05 m/kg and Inj. Glycopyrrolate
0.008mg/kg. Inj. Diclofenac sodium 75mg will be given IV for analgesia at the
end of surgery.
Noninvasive arterial blood pressure (NIBP), Electrocardiography(ECG), pulse
oximetry and end-tidal carbon dioxide, (ETCO2) will be monitored
. continuously.
The patient will be extubated and transferred to PACU.Requirement of total analgesics within 24 hours will be noted. |
| Intervention |
Thoracic segmental spinal anaesthesia |
The patient will be placed in a sitting position for spinal anaesthesia. Under all
aseptic and antiseptic precautions, painting and draping of the thoracolumbar
area will be done. After skin infiltration with 2% lignocaine at puncture Site
(T10-11) or (T9-T10).
The Spinal puncture will be performed via a median approach with a 25-G
Quincke spinal needle. Once ligamentum flavum was pierced, the needle’s stylet
was removed and the hub was observed for the free flow of CSF.
A maximum of two attempts will be allowed to localize the spinal space. After
confirming the free flow of clear CSF, a mixture of 1mL 0.5% isobaric
levobupivacaine and 25μg of fentanyl (total volume 1.5mL) will be injected.
Patients will be then placed in the supine position.
Onset of action and level of sensory block will be judged by pin prick method
every minute until the establishment of desired block at desired level.
Patients will be given 6 Litre/min O2 Inhalation via Venti mask.
Noninvasive arterial blood pressure (NIBP), Electrocardiography(ECG), pulse
oximetry and end-tidal carbon dioxide, (ETCO2) will be monitored continuously.
Patient will be transferred to PACU after Surgery. Requirement of total analgesics within 24 hours will be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients weighing 40-80 Kgs.
Patient with height 140-180 cms.
American Society of Anesthesiology (ASA) grade 1 & 2
Patients posted for Laparoscopic Appendicectomy. |
|
| ExclusionCriteria |
| Details |
Pregnant Females.
Patient with spine deformities.
Patient with any Coagulopathy or Bleeding Disorders.
Patients with allergy to local Anaesthetics.
Patients with infection at site of Spinal Injection.
Patient with History of Hypertension, Ischemic Heart disease, Valvular Heart diseases, Liver diseases, Renal or CNS diseases.
Patients with history of drug abuse. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in intraoperative Hemodynamic and Respiratory parameters such as Heart Rate,
Systolic blood pressure, Diastolic blood pressure, Mean Arterial Blood
Pressure, SpO2, Respiratory Rate, EtCO2. Effect on post operative analgesia and requirement of post operative analgesics. |
at baseline and then upto 90 mins intraoperatively , and 24 hours post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects such as Nausea, Vomiting, Shoulder tip pain, Urinary retention |
during or after the surgery upto 24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/09/2024 |
| 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="3"
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 - NO
|
|
Brief Summary
|
This study compares the effectiveness of general anesthesia versus thoracic segmental spinal anesthesia for laparoscopic appendicectomy. Given the limited data on spinal anesthesia for this procedure, the research evaluates hemodynamic stability, postoperative analgesia, rescue analgesic requirements, surgeon satisfaction, muscle relaxation, and side effects such as postoperative nausea and vomiting (PONV), urinary retention, and shoulder tip pain. The goal is to determine whether spinal anesthesia offers benefits like reduced PONV, decreased postoperative pain, quicker mobilization, and better patient orientation post-surgery compared to general anesthesia. Thus it will help anaesthetists to decide mode of anaesthesia for laparoscopic appencidecromy. |