No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery

Completed

• Conditions: Umbilical Hernia; Inguinal Hernia, Direct; Cholecystitis

• Registration Number: NCT02782832
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

This study analyse the need for neuromuscular blockade in consecutive routine laparoscopic procedures without standard use of neuromuscular blockade in an ambulatory laparoscopic surgery setting and analyse specific reasons for using neuromuscular blockade in individual patients. Furthermore, the study report the analgesic use in postoperative care unit and the discharge rate.

Detailed Description

The study is retrospective, including consecutive patients in an unrestricted referral of patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair. Inclusion period was from 01.04.2013 to 31.03.2015. All patients received general anesthesia using propofol (2 mg/kg) and remifentanil (1 μg/kg/min) for induction. In patients where tracheal intubation was required, this was done without use of neuromuscular blocking drug; otherwise a proseal laryngeal mask was used. For the maintenance of anesthesia, additional continuous infusion of propofol (3-5 mg/kg/h) and remifentanil (0.3-0.5 μg/kg/min) was used. Data were derived from a prospective local database on demographics, anesthetic methods and supplements (i.e. need for neuromuscular blockade) and postoperative needs for supplementary analgesics besides the postoperative standard analgesic regimen, number of hours stayed in the ambulatory surgery department, and discharge rate (including reasons for hospital admittance).

Study Timeline

• Study First Submitted: 2016-02-15
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-25
• Primary Completion: 2016-06
• Study Completion: 2016-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1245

Inclusion Criteria

• patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients requiring neuromuscular blockade	At time of surgery	Data derived from a prospective local database on need for neuromuscular blockade in patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair.

Secondary Outcome Measures

Name	Time	Method
Analgesic use in postoperative care unit	Within 6 hours after surgery	Amount of opioids administered to the patients in the postoperative care unit
Hours stayed in the postoperative care unit	1 to 6 hours after surgery
Maximum Visual analog score (VAS) for pain in the postoperative Care unit	1 to 6 hours after surgery