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CompletedNCT02782832Updated May 29, 2018

No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery

An observational study in Cholecystitis, Inguinal Hernia, Direct and Umbilical Hernia, sponsored by Hvidovre University Hospital. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-29.

Sponsored by Hvidovre University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,245
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Cholecystitis
  • Inguinal Hernia, Direct
  • Umbilical Hernia

Keywords

  • Neuromuscular
  • Blockade
  • Surgery
03

In context

Cholecystitis

192 studies on the registry are indexed under Cholecystitis; 36 are open to participants now.

This study's enrollment of 1,245 is above the median of 222 across 55 observational studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,245 participants (actual)
Patient registry
No
06

What researchers measure

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.

    Time frame: At time of surgery

Secondary outcomes

  1. Analgesic use in postoperative care unit

    Amount of opioids administered to the patients in the postoperative care unit

    Time frame: Within 6 hours after surgery

  2. Hours stayed in the postoperative care unit

    Time frame: 1 to 6 hours after surgery

  3. Maximum Visual analog score (VAS) for pain in the postoperative Care unit

    Time frame: 1 to 6 hours after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. Erratum In: Anesth Analg. 2015 Apr;120(4):957. Dosage error in article text. PubMed 24977638 ↗
  • 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. PubMed 23461992 ↗
  • 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. PubMed 24240315 ↗
  • 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. PubMed 25625254 ↗
  • 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. PubMed 19821409 ↗
  • 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. PubMed 12582754 ↗
  • 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. PubMed 9112891 ↗
  • 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. PubMed 12960786 ↗
  • 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. PubMed 11360058 ↗
  • Loven H, Kristensen BB, Bisgaard T. Low admittance rate after ambulatory laparoscopic surgery. Dan Med J. 2019 Jun;66(6):A5547. PubMed 31256774 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2016, a primary completion of Jun 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2016
First posted
May 25, 2016
Start
May 2016
Primary completionActual
Jun 2016
CompletionActual
Aug 2016
Last update
May 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02782832
Responsible party
Billy B Kristensen (Chief Physician, Hvidovre University Hospital) — Principal investigator
First posted
May 25, 2016
Start date
May 2016
Primary completion
Jun 2016
Completion
Aug 2016
Last update
May 29, 2018

Study contacts

Billy B Kristensen, MD
principal investigator · Hvidovre University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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