| CTRI Number |
CTRI/2026/04/109011 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
safety and feasibility of laproscopic appendectomy under spinal vs general anaesthesia |
|
Scientific Title of Study
|
Comparison 0f feasibility and safety of laparoscopic appendectomy under spinal anaesthesia vs general anaesthesia prospective interventional comparative 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 Shivani Goswami |
| Designation |
junior resident |
| Affiliation |
shri bm patil medical college |
| Address |
department of general surgery shri bm Patil medical college blde deemed to be university Vijaypura karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9354440812 |
| Fax |
|
| Email |
shivanigoswami103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish Kullolli |
| Designation |
professor |
| Affiliation |
shri bm patil medical college |
| Address |
department of general surgery shri bm patil medical college blde campus deemed to be university vijaypura
Bijapur
KARNATAKA
586103
India |
| Phone |
9482666444 |
| Fax |
|
| Email |
girish.kullolli@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girish Kullolli |
| Designation |
professor |
| Affiliation |
shri bm patil medical college |
| Address |
department of general surgery shri bm patil medical college blde campus deemed to be university vijaypura
KARNATAKA
586103
India |
| Phone |
9482666444 |
| Fax |
|
| Email |
girish.kullolli@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| Dr shivani goswami
Junior resident department of general surgery 2nd floor shri bm patil medical college blde deemed to be university Vijaypura Karnataka , India 586103 |
|
|
Primary Sponsor
|
| Name |
Dr shivani Goswami |
| Address |
Junior resident department of general surgery 2nd floor shri bm patil medical college blde deemed to be university vijaypura karnataka india 586103 |
| Type of Sponsor |
Other [self] |
|
|
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 shivani goswami |
Shri BM Patil medical college blde deemed to be university Vijaypura |
Department of general surgery 2nd floor Shri BM Patil medical college blde deemed to be university Vijaypura karnataka india 586103
Bijapur
KARNATAKA |
9354440812
shivanigoswami103@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| blde deemed to be university ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
General anesthesia for laproscopic appendectomysurgery |
General anaesthesia is typically initiated after thorough preoperative assessment, where the
patients medical history, airway status, fasting status, and relevant investigations are reviewed.
This ensures patient safety and helps plan anaesthesia appropriately. Premedication is usually
administered 30–60 minutes before surgery to reduce anxiety and minimise gastric acidity.
Common agents include midazolam 1–2 mg IV for anxiolysis, ranitidine 50 mg IV or
pantoprazole 40 mg IV to reduce gastric acid, and ondansetron 4 mg IV for antiemetic effect.
Induction of anaesthesia is done in the operating room using intravenous agents. Common
induction agents include propofol 1.5–2.5 mg/kg IV, thiopentone sodium 3–5 mg/kg IV, or
etomidate 0.2–0.3 mg/kg IV, selected based on patient condition. For analgesia, opioids such as
fentanyl 1–2 mcg/kg IV or morphine 0.1 mg/kg IV may be administered. Muscle relaxants like
succinylcholine 1–1.5 mg/kg IV (for rapid onset) or rocuronium 0.6–1.2 mg/kg IV (longer
acting) are given to facilitate intubation. Once the patient is adequately relaxed, airway
management is performed by inserting an endotracheal tube or a supraglottic airway device (e.g.,
LMA). Proper placement is confirmed via capnography and auscultation. Maintenance of
anaesthesia involves continuing inhalational agents like sevoflurane (1–2%), isoflurane (0.5–
1.5%), or desflurane (4–8%), along with intermittent doses or infusions of opioids and muscle
relaxants like atracurium (0.3–0.6 mg/kg IV bolus or infusion). Ventilation is closely monitored
throughout. Emergence begins once surgery ends. Inhalational agents are discontinued, and
neuromuscular blockade is reversed using neostigmine 0.05 mg/kg IV and glycopyrrolate 0.01
mg/kg IV. The patient regains consciousness and protective airway reflexes. Finally, during the
recovery phase, the patient is monitored in the post-anaesthesia care unit (PACU) for stable vital
signs, adequate respiration, pain control (e.g., paracetamol 1 g IV), and postoperative nausea and
vomiting. |
| Intervention |
Spinal anesthesia for open appendectomy surgery |
Preoperative Preparation Patient assessment: Medical history, allergies, and
contraindications (e.g., coagulopathy, infection at the site). Informed consent: Explain
procedure, risks, and benefits. Monitoring: Attach monitors (ECG, pulse oximeter,
NIBP). IV access: Secure a wide-bore intravenous line. Hydration: Administer IV fluids
to prevent hypotension.
Positioning the Patient: Common positions: Sitting position (preferred for obese or
elderly patients), Lateral decubitus position (if sitting is not possible). Ensure a flexed
spine ("mad cat" position) to widen intervertebral spaces.
Aseptic Technique: Clean the back with an antiseptic solution (e.g., povidone-iodine or
chlorhexidine). Drape the area with sterile drapes. Wear sterile gloves, a mask, and a
gown.
Identifying the Injection Site: It is usually at the L3–L4 or L4–L5 interspace. Locate the
iliac crests to identify the L4 vertebra.
Local Anaesthesia Infiltrate skin and subcutaneous tissue with local anaesthetic (e.g.,
lidocaine 1%) at the planned puncture site.
Spinal Needle Insertion Use a 25G or 27G Quincke or pencil-point spinal needle. Insert
through the intervertebral space until cerebrospinal fluid (CSF) appears. Confirm clear,
free-flowing CSF.
Drug Injection: Inject local anaesthetic into the subarachnoid space. Common agents:
Bupivacaine 0.5% heavy, typically 2.5–3 ml. Additives like fentanyl may be included for
better analgesia. Inject slowly over 10–15 seconds, then withdraw the needle.
Positioning for Surgery Trendelenburg position (head down) may be used to achieve
higher sensory levels (T4–T6) for upper abdominal surgeries. Assess block height before
9. starting surgery (cold swab or pinprick test). Monitor for signs of high spinal
(bradycardia, hypotension, difficulty breathing).
Intraoperative Monitoring: Continuously monitor vital signs. Treat hypotension with
fluids and vasopressors (e.g., ephedrine or phenylephrine). Manage bradycardia with
atropine if needed. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of any age group and gender admitted to B.L.D.E. (D.U) Shri B. M. Patil
Medical College and Research Centre with acute appendicitis undergoing laparoscopic
appendectomy.
ASA 1,2 |
|
| ExclusionCriteria |
| Details |
Bleeding disorders
Hepatic disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare intraoperative adverse effects between spinal anesthesia and general
anesthesia in patients undergoing laparoscopic appendectomy
To compare post operative pain score (VAS) between spinal anesthesia and general
anesthesia in patients undergoing laparoscopic appendectomy. |
1 , 4, 8, 24 hours post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| study the preoperative tolerance & postoperative complications in patients undergoing laproscopic appendectomy in general & spinal anaesthesia |
1 4 8 24 hours post op |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
patients posted for laproscopic appendectomy is divided into group of 45 people randomly into group of 2 one given general anesthesia and other group given spinal anesthesia intra op vitals are observed and post op recovery is observed as vas score |