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Completed

NCT Number: NCT03420937

Deep Neuromuscular Block During General Anaesthesia in Robotic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

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

Olomouc, 77520, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sugammadex

Drug

Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.

Other names: Bridion

Neostigmine, Atropin Biotika

Drug

Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.

Other names: syntostigmine, atropine

Primary outcomes

  1. Surgical conditions SRS

    Time frame: Perioperative period

    Describes the quality of surgical conditions as reported by surgeon

  2. Intraabdominal pressure IAP (mmHg)

    Time frame: During surgery

    Pressure in the abdominal cavity during capnoperitoneum

Secondary outcomes

  1. Operating theatre time (min)

    Time frame: during anesthesia

    Time from induction to anesthesia to the release from operating theatre

  2. Post-operative recovery

    Time frame: post-operative period (1 week)

    Physiological functions, level of discomfort, subjective evaluation by the patient

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Collaborators

  • Palacky University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2018
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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