No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery

NCT02782832 | Completed DMC

• 1 other identifier: DagKir-neuromus block
• Study Type: observational
• Target: 1,245
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cholecystitis; Inguinal Hernia, Direct; Umbilical Hernia

Keywords

Neuromuscular; Blockade; Surgery

Outcome Measures

Primary Outcomes (1)

• Number of patients requiring neuromuscular blockade

  Data derived from a prospective local database on need for neuromuscular blockade in patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair.

  At time of surgery

Secondary Outcomes (3)

• Analgesic use in postoperative care unit

  Within 6 hours after surgery

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair

You may not qualify if:

• None

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Related Publications (10)

• 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.

  PMID: 24977638 BACKGROUND

• Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Gatke MR. Optimized surgical space during low-pressure laparoscopy with deep neuromuscular blockade. Dan Med J. 2013 Feb;60(2):A4579.

  PMID: 23461992 BACKGROUND

• Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.

  PMID: 24240315 BACKGROUND

• Kopman AF, Naguib M. Laparoscopic surgery and muscle relaxants: is deep block helpful? Anesth Analg. 2015 Jan;120(1):51-58. doi: 10.1213/ANE.0000000000000471.

  PMID: 25625254 BACKGROUND

• Abrishami A, Ho J, Wong J, Yin L, Chung F. Sugammadex, a selective reversal medication for preventing postoperative residual neuromuscular blockade. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD007362. doi: 10.1002/14651858.CD007362.pub2.

  PMID: 19821409 BACKGROUND

• Barczynski M, Herman RM. A prospective randomized trial on comparison of low-pressure (LP) and standard-pressure (SP) pneumoperitoneum for laparoscopic cholecystectomy. Surg Endosc. 2003 Apr;17(4):533-8. doi: 10.1007/s00464-002-9121-2. Epub 2003 Feb 17.

  PMID: 12582754 BACKGROUND

• Wallace DH, Serpell MG, Baxter JN, O'Dwyer PJ. Randomized trial of different insufflation pressures for laparoscopic cholecystectomy. Br J Surg. 1997 Apr;84(4):455-8.

  PMID: 9112891 BACKGROUND

• Perrakis E, Vezakis A, Velimezis G, Savanis G, Deverakis S, Antoniades J, Sagkana E. Randomized comparison between different insufflation pressures for laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2003 Aug;13(4):245-9. doi: 10.1097/00129689-200308000-00004.

  PMID: 12960786 BACKGROUND

• 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.

  PMID: 11360058 BACKGROUND

• Loven H, Kristensen BB, Bisgaard T. Low admittance rate after ambulatory laparoscopic surgery. Dan Med J. 2019 Jun;66(6):A5547.

  PMID: 31256774 DERIVED

MeSH Terms

Conditions

Cholecystitis; Hernia, Inguinal; Hernia, Umbilical

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral

Study Officials

• Billy B Kristensen, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: May 25, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share