Clinical trial NCT02782832: No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery
Official title: No Need for Neuromuscular Blockade in Day Case Standardised Laparoscopic Surgery. A Consecutive Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystitis
Inguinal Hernia, Direct
Umbilical Hernia
Keywords: Neuromuscular
Blockade
Surgery
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 1245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective study, including consecutive patients in an unrestricted referral of patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair

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).

Eligibility criteria: Inclusion Criteria:

* patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of patients requiring neuromuscular blockade
timeFrame: At time of surgery
Secondary outcomes:
measure: Analgesic use in postoperative care unit
timeFrame: Within 6 hours after surgery
measure: Hours stayed in the postoperative care unit
timeFrame: 1 to 6 hours after surgery
measure: Maximum Visual analog score (VAS) for pain in the postoperative Care unit
timeFrame: 1 to 6 hours after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Hvidovre University Hospital
name: Billy B Kristensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, Gatke MR. Surgical space conditions during low-pressure laparoscopic cholecystectomy with deep versus moderate neuromuscular blockade: a randomized clinical study. Anesth Analg. 2014 Nov;119(5):1084-92. doi: 10.1213/ANE.0000000000000316.
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citation: Larsen JF, Ejstrud P, Kristensen JU, Svendsen F, Redke F, Pedersen V. Randomized comparison of conventional and gasless laparoscopic cholecystectomy: operative technique, postoperative course, and recovery. J Gastrointest Surg. 2001 May-Jun;5(3):330-5. doi: 10.1016/s1091-255x(01)80056-1.
citation: Loven H, Kristensen BB, Bisgaard T. Low admittance rate after ambulatory laparoscopic surgery. Dan Med J. 2019 Jun;66(6):A5547.