No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery

Cholecystitis Clinical Trial

Official title:

No Need for Neuromuscular Blockade in Day Case Standardised Laparoscopic Surgery. A Consecutive Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782832
• Other study ID #: DagKir-neuromus block
• Status: Completed
• Start date: May 2016
• Est. completion date: August 2016

Study information

• Verified date: May 2018
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1245
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair

Exclusion Criteria:

Related Conditions & MeSH terms

• Cholecystitis
• Hernia
• Hernia, Inguinal
• Hernia, Umbilical
• Inguinal Hernia, Direct
• Umbilical Hernia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

References & Publications (9)

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. Review. — View Citation

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. Epub 2003 Feb 17. — View Citation

Kopman AF, Naguib M. Laparoscopic surgery and muscle relaxants: is deep block helpful? Anesth Analg. 2015 Jan;120(1):51-8. doi: 10.1213/ANE.0000000000000471. Review. — View 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. — View Citation

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. — View Citation

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. — View Citation

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

Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, Gätke 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. Erratum in: Anesth Analg. 2015 Apr;120(4):957. Dosage error in article text. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analgesic use in postoperative care unit	Amount of opioids administered to the patients in the postoperative care unit	Within 6 hours after surgery
Secondary	Hours stayed in the postoperative care unit		1 to 6 hours after surgery
Secondary	Maximum Visual analog score (VAS) for pain in the postoperative Care unit		1 to 6 hours after surgery