Low-pressure vs Standard-pressure in Laparoscopic Cholecystectomy

NCT04146090 | Completed DMC

• 1 other identifier: CAAE 18245019.6.0000.5373
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Many studies have demonstrated reduced postoperative pain in patients undergoing lower pneumoperitoneum pressure level during laparoscopic cholecystectomy. However, most of them has shown a high risk of bias and low or very low quality of evidence. Considering the need to evaluate, not only the postoperative pain, but the effect of anesthesia and surgery on patient recovery and satisfaction, we have designed a prospective, randomised and double-blinded study to evaluate the quality of recovery, using the Quality of Recovery Questionnaire (QoR-40), in patients undergoing LC under low-pressure or standard pressure pneumoperitoneum. Methods. Eighty patients aged 18 to 65 years of age will be randomised into 2 groups: LP (low-pressure - 10mmHg) or S (standard - 14 mmHg) enrolled in the study. Anesthesia will be induced with remifentanil, propofol and rocuronium and the maintenance will be achieved with sevoflurane and remifentanil Anesthesiologists and surgeons will not have access to insufflation pressure display. The primary outcome will be assessed using the Quality of Recovery Questionnaire (QoR-40) which is a 40-item quality of recovery scoring system. In addition, the intraoperative rocuronium consumption, time to eye opening (time from the discontinuation of anesthetics to eye opening), post-operative nausea and vomiting, pain score, analgesic use, and length of PACU stay (time to Aldrete score ≥ 9) will be recorded.

Conditions

Laparoscopic Surgery; Pneumoperitoneum; Cholecystitis; Choledocholithiasis; Quality of Life; Postoperative Nausea and Vomiting; Postoperative Pain; Satisfaction, Patient

Outcome Measures

Primary Outcomes (1)

• Quality of recovery

  The primary outcome will be assessed using the Quality of Recovery Questionnaire (QoR-40) which is a 40-item quality of recovery scoring system

  24 hours after surgery

Secondary Outcomes (5)

• Postoperative pain

  The severity of pain was measured at 15-min intervals during PACU stay and at 4, 6, and 24 hours after surgery

• Postoperative nausea and vomiting

  24 hours

• Intraoperative rocuronium consumption

  Intraoperative

• Time to eye opening

  Intraoperative (During recovery in operation room)

• Surgical working conditions

  Intraoperative

Study Arms (2)

Low-pressure

ACTIVE COMPARATOR

Forty patients aged 18 to 65 years, with an ASA physical status I or II, who will be scheduled to undergo laparoscopic cholecystectomy

Other: Low-pressure pneumoperitoneum

Standard pressure

PLACEBO COMPARATOR

Forty patients aged 18 to 65 years, with an ASA physical status I or II, who will be scheduled to undergo laparoscopic cholecystectomy

Other: Standard pressure pneumoperitoneum

Interventions

Low-pressure pneumoperitoneum OTHER

Pneumoperitoneum will be maintained in 10 mmHg

Low-pressure

Standard pressure pneumoperitoneum OTHER

Pneumoperitoneum will be maintained in 14 mmHg

Standard pressure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an ASA physical status I or II, who will be scheduled to undergo LC

Sponsors & Collaborators

• Pontificia Universidade Catolica de Sao Paulo: lead

Study Sites (1)

Eduardo T Moro

Araçoiaba da Serra, São Paulo, 18190-000, Brazil

Location

MeSH Terms

Conditions

Pneumoperitoneum; Cholecystitis; Choledocholithiasis; Postoperative Nausea and Vomiting; Pain, Postoperative; Patient Satisfaction

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Common Bile Duct Diseases; Bile Duct Diseases; Cholelithiasis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomised in a 1:1 ratio (www.random.org) into 2 groups: LP (low-pressure) or S (standard). Group assignments will be sealed in sequentially numbered opaque envelopes that will be opened after patient inclusion into the study. Care providers, researchers, and patients will be blinded to group assignments.Insufflation pressure will be maintained in 14 mmHg (group S) or 10 mmHg (group LP). Anesthesiologists and surgeons will not have access to insufflation pressure display (it will be covered by an opaque paper and will be set by operating room personnel).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double blinded, randomised controlled trial

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: October 23, 2019
• Primary Completion: January 6, 2021
• Study Completion: February 10, 2021
• Last Updated: April 2, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)