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Clinical Trials/NCT03890406
NCT03890406
Completed
Not Applicable

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

Seoul National University Bundang Hospital1 site in 1 country88 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Anesthesia
Sponsor
Seoul National University Bundang Hospital
Enrollment
88
Locations
1
Primary Endpoint
Dosage of propofol
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
March 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

BON WOOK KOO

Assistant professor

Seoul National University Bundang Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Dosage of propofol

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

the amount of propofol used (mg/kg)

Secondary Outcomes

  • Patient self respiration(intraoperative (from tracheal intubation to injection of neuromuscular reversal agent))
  • Dosage of remifentanil(intraoperative (from starting of anesthesia to end of anesthesia))
  • Patient movement(intraoperative (from tracheal intubation to injection of neuromuscular reversal agent))
  • Surgical condition score(assessed at the end of the surgery)

Study Sites (1)

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