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NCT Number: NCT03890406

The Effect of Deep Neuromuscular Blockade on Requirement of Intravenous Anesthetic Agent

Recently, deep neuromuscular blockade during general anesthesia has been studied by many authors regarding various effects upon patients' outcomes and surgical conditions. We believe deep neuromuscular blockade can be especially beneficial in laparoscopic surgery, because it can expand surgical space and prevent patients' minute movements that can disturb precise operations. In clinical situations, anesthetists tend to compensate the insufficiency of neuromuscular blockade by increasing the dose of other anesthetic agents, which can prolong patients' recovery time and impair the surgical condition. In this study, we plan to divide the patients into 2 groups according to the depth of neuromuscular blockade, and compare the dose of anesthetic agent used to maintain surgical condition.

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Key information

Conditions

Laparoscopy General Anesthesia Neuromuscular Blockade

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

Patients undergoing elective laparoscopic colorectal surgery are going to be recruited and divided into 2 groups: Group D will receive deep neuromuscular blockade, and Group M will receive moderate neuromuscular blockade using continuous infusion of rocuronium. Acceleromyography(TOF-watch SX) will be used to monitor the depth of blockade. In both groups, the anesthesia will be maintained with TIVA(total intra-venous anesthesia) including continuous target-controlled infusion of propofol and remifentanil. During the surgery, the number of patient movement and restoration of self respiration will be recorded. At the end of anesthesia, the dose of propofol and remifentanil used will be assessed and compared between the groups. Also, the satisfaction score of surgeons regarding the surgical condition, the anesthesia time, the operation time will be documented. After the patients are discharged, their charts are going to be reviewed and whether any pulmonary or surgical complications occurred will be documented.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing elective laparoscopic colorectal resection due to benign or malignant neoplasm of colon or rectum
  • ASA class I or II

Exclusion criteria

  • Patients receiving medications known to have drug-drug interaction with neuromuscular blocking agents
  • Patients who have significantly impaired cardiac, pulmonary, hepatic, renal function
  • Patients who are pregnant
  • Patients who are known to have hypersensitivity to the anesthetic/analgesic/neuromuscular blocking agents which are going to be used in the study
  • BMI < 18.5 or > 35.0 kg/m2
  • Patients with previous history of open abdominal surgery
  • Patients with previous history of malignant hyperthermia

Treatment and study plan

Rocuronium: PTC(Post-tetanic count) 1~2

Drug

Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.

Other names: Deep block

Rocuronium: TOF(Train-of-four) 1~2

Drug

Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.

Other names: Moderate block

Primary outcomes

  1. Dosage of propofol

    Time frame: intraoperative (from starting of anesthesia to end of anesthesia)

    the amount of propofol used (mg/kg)

Secondary outcomes

  1. Dosage of remifentanil

    Time frame: intraoperative (from starting of anesthesia to end of anesthesia)

    the amount of remifentanil used (mcg/kg)

  2. Patient movement

    Time frame: intraoperative (from tracheal intubation to injection of neuromuscular reversal agent)

    the observed number of patient movement during the surgery

  3. Patient self respiration

    Time frame: intraoperative (from tracheal intubation to injection of neuromuscular reversal agent)

    the observed number of restoration of self breathing during the surgery (ex. EtCO2 notching)

  4. Surgical condition score

    Time frame: assessed at the end of the surgery

    the 5-point satisfaction score of surgeon regarding surgical conditions

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

The Effect of Deep Neuromuscular Blockade on Requirement of Intravenous Anesthetic Agent During Laparoscopic Colorectal Surgery

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 26, 2019
Registry last updated
Jun 30, 2020

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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