No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery

May 25, 2018 updated by: Billy B Kristensen, Hvidovre University Hospital

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

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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

1245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • patients undergoing laparoscopic cholecystectomy, umbilical and inguinal hernia repair

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients requiring neuromuscular blockade
Time Frame: At time of surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic use in postoperative care unit
Time Frame: Within 6 hours after surgery
Amount of opioids administered to the patients in the postoperative care unit
Within 6 hours after surgery
Hours stayed in the postoperative care unit
Time Frame: 1 to 6 hours after surgery
1 to 6 hours after surgery
Maximum Visual analog score (VAS) for pain in the postoperative Care unit
Time Frame: 1 to 6 hours after surgery
1 to 6 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Billy B Kristensen, MD, Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 25, 2016

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DagKir-neuromus block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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