No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery

NCT ID: NCT02782832

Last Updated: 2018-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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).

Conditions

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Cholecystitis Inguinal Hernia, Direct Umbilical Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Billy B Kristensen

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Billy B Kristensen, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

References

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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.

Reference Type BACKGROUND
PMID: 24977638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23461992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24240315 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25625254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19821409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12582754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9112891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12960786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11360058 (View on PubMed)

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

Reference Type DERIVED
PMID: 31256774 (View on PubMed)

Other Identifiers

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DagKir-neuromus block

Identifier Type: -

Identifier Source: org_study_id

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