A trial of conducting an operation of removal of gall bladder by giving anaesthesia via injecting it in the back/spine leading to loss of sensation in lower part of the body (spinal anaesthesia) or by giving inhalation sedatives leads to complete sedation of the patient (general anaesthesia)

A prospective randomized control trial: Experience of laparoscopy cholecystectomy under spinal anaesthesia

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032197

Enrollment

100

Registered

2021-03-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Group B- Laparoscopic cholecystectomy under spinal anaesthesia: Two groups are made by using randomization method, Group A will undergo laparoscopic cholecystectomy under general anaest

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with cholelithiasis planned for elective laparoscopic cholecystectomy. 2. Age 20-70 years. 3. ASA group I, II and III.

Exclusion criteria

Exclusion criteria: 1. ASA group IV, V and VI. 2. Acute cholecystitis or cholangitis or acute pancreatitis. 3. Patient with bleeding diathesis. 4. Local spinal deformity. 5. Chronic Obstructive Pulmonary Disease. 6. Pregnancy.

Design outcomes

Primary

Measure	Time frame
1.To compare the operative time. a.Mean anaesthesia time. b.Pneumoperitoneum time. c.Surgery time. 2.To compare the intra-operative surgical comfort of the surgeon (by questionnaire developed by the investigator). 3.To compare the intra-operative events i.e. anxiety, right shoulder tip pain, and vomiting.Timepoint: Intraopoeratively, any of the complaints will be asked at an interval of 15 minutes.	—

Measure

Time frame

1.To compare the operative time. a.Mean anaesthesia time. b.Pneumoperitoneum time. c.Surgery time. 2.To compare the intra-operative surgical comfort of the surgeon (by questionnaire developed by the investigator). 3.To compare the intra-operative events i.e. anxiety, right shoulder tip pain, and vomiting.Timepoint: Intraopoeratively, any of the complaints will be asked at an interval of 15 minutes.

—

Secondary

Measure	Time frame
1.To compare the conversion rate from spinal anaesthesia to general anaesthesia. 2.To compare the post-operative pain by visual analogue scale (VAS). 3.To compare the post-operative nausea and vomiting. 4.To compare the hospital stay. Timepoint: Post-operative monitoring at 0 hour, 3 hours, 6 hours, 12 hours and 26 hours	—

Countries

India

Contacts

Public ContactDr Rajat Kumar Verma

LHDM and Dr Prem Hospital

abk123k@gmail.com9817159461

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026