Study of cholecystectomy outcomes with low pressure pneumoperitoneum and deep neuromuscular blockade

Low pressure pneumoperitoneum versus standard pressure pneumoperitoneum in patient undergoing laparoscopic cholecystectomy with deep neuromuscular blockade: a randomized non inferiority control trial. - COLD trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077614

Enrollment

172

Registered

2024-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis Health Condition 2: K801- Calculus of gallbladder with othercholecystitis Health Condition 3: K810- Acute cholecystitis Health Condition 4: K811- Chronic cholecystitis Health Condition 5: K812- Acute cholecystitis with chronic cholecystitis

Interventions

Intervention1: Low pressure pneumoperitoneum in patient undergoing laparoscopic cholecystectomy: Low pressure pneumoperitoneum in patient undergoing laparoscopic cholecystectomy under deer NMB. Surger

Eligibility

Inclusion criteria

Inclusion criteria: Patient aged 18 or above with ASA grade 1 or 2 undergoing laparoscopic cholecystestomy.

Exclusion criteria

Exclusion criteria: Emergency surgery or history of upper abdominal surgery or BMI more than thirty five or Patient having NMD or drug allergy or Intra operative duration more than hundred minutes or difficult laparoscopic cholecystectomy based on pre operative clinical assessment.

Design outcomes

Primary

Measure	Time frame
Quality of surgical field, assessed using a Leiden surgical rating scaleTimepoint: Intraoperative assessment	—

Secondary

Measure	Time frame
Postoperative pain measured by VAS score Postoperative complication ( shoulder pain ,nausea ,vomiting, cardiovascular symptoms, respiratory symptoms Recovery time Duration of surgeryTimepoint: Secondary outcomes will be asses till POD 2.	—

Countries

India

Contacts

Public ContactDr Bikram Rout

AIIMS BHUBANESWAR

surg_bikram@aiimsbhubaneswar.edu.in8763278543

Outcome results

None listed

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