Deep Neuromuscular Block During General Anaesthesia in Robotic Surgery

January 26, 2018 updated by: MUDr. Lenka Doubravska, University Hospital Olomouc

Deep Neuromuscular Block During General Anaesthesia in Laparoscopic (and Robotic Laparoscopic) Surgery and Its Potential Benefits for Certain Physiological Parameters in Perioperative Period

The aim of this project is to show, whether the use of the deep neuromuscular block in certain laparoscopic robot-assisted surgery can positively influence main physiological functions compared to the use of standard neuromuscular block. Secondary outcome is to find out whether the targeted specific reversal of neuromuscular block by sugammadex improves and fastens the post-operative recovery of the patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adequate muscle relaxation during general anaesthesia is crucial for easy, uncomplicated and safe laparoscopic and robot-assisted surgery. Perfect abdominal wall relaxation facilitates surgical working conditions, which makes surgery safer, faster and easier to perform. Besides this indirect advantage, there could be obvious benefit for patients. This is a result of decreased negative pathophysiological consequences of an increased intraabdominal pressure (capnoperitoneum) on important organ systems (cardiovascular, breathing system, kidneys etc.) Complete muscle relaxation during general anaesthesia can be achieved by using higher doses of rocuronium (non-depolarizing aminosteroid muscle relaxant) and special anaesthetic technique called deep neuromuscular block (DNMB). The primary focus of the project is to test the potential advantages of DNMB compared to standard relaxation technique. Safe and efficient use of NMBA is an important precondition in restoring a patient´s full muscle strength at the end of anaesthesia, to prevent effects of residual block. Modern practice of anaesthesia offers an option for complete and immediate rocuronium induced block reversal by using its specific antagonist - sugammadex. Combination of DNMB approach and sugammadex reversal also provide potential benefits for perioperative course and patient recovery after surgery. Secondary objective of the project is to verify this facts.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Olomouc, Czechia, 77520
        • Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc

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

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age over 18 years
  • Informed Consent
  • Elective robotic radical prostatectomy
  • American Society of Anesthesiologists (ASA) status 1-3

Exclusion Criteria:

  • Inability to obtain Informed ConsentAge under 18 years
  • American Society of Anesthesiologists (ASA) status over 3
  • Indication for rapid sequence induction, signs of difficult airway severe neuromuscular, liver or renal disease
  • Known allergy to drugs used in the study
  • Malignant hyperthermia (medical history)

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Deep Neuromuscular Block

Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Post-tetanic Count (PTC) = 1-2; PTC measurement every 4 min.

Intervention: Neuromuscular blockade reversal at the end of anesthesia: sugammadex 2 mg/kg iv (when PTC is 18-20 and TOF-count 0) or sugammadex 4 mg/kg iv (when PTC under 18).

Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1,5-2,5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv.

Extubation when patient is conscious and attained recovery from neuromuscular blockade to a TOF-ratio of at least 0,9.
Drug: Sugammadex
Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.
Other Names:
  • Bridion
EXPERIMENTAL: Moderate Neuromuscular Block
Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Train-of-Four (TOF) count = 1-2, TOF-count measurement every 1 min. Intervention: Neuromuscular blockade reversal at the end of anesthesia: neostigmine 0.03 mg/kg iv + atropine 0.5-1.0 mg iv Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1.5-2.5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv Extubation when patient is conscious and attained the recovery from neuromuscular blockade to a TOF-ratio of at least 0,9.
Drug: Neostigmine, Atropin Biotika
Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.
Other Names:
  • syntostigmine, atropine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical conditions SRS
Time Frame: Perioperative period
Describes the quality of surgical conditions as reported by surgeon
Perioperative period
Intraabdominal pressure IAP (mmHg)
Time Frame: During surgery
Pressure in the abdominal cavity during capnoperitoneum
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating theatre time (min)
Time Frame: during anesthesia
Time from induction to anesthesia to the release from operating theatre
during anesthesia
Post-operative recovery
Time Frame: post-operative period (1 week)
Physiological functions, level of discomfort, subjective evaluation by the patient
post-operative period (1 week)

Collaborators and Investigators

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

Sponsor

University Hospital Olomouc

Collaborators

Palacky University

Investigators

  • Principal Investigator: Karel Axmann, MD, University Hospital Olomouc

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 (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

May 22, 2016

First Submitted That Met QC Criteria

January 26, 2018

First Posted (ACTUAL)

February 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGA_LF_2016_021

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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