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

Not Applicable

Completed

• Conditions: Neuromuscular Blockade; Laparoscopy; General Anesthesia

• Registration Number: NCT03890406
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Study Start: 2019-04-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dosage of propofol	intraoperative (from starting of anesthesia to end of anesthesia)	the amount of propofol used (mg/kg)

Secondary Outcome Measures

Name	Time	Method
Patient self respiration	intraoperative (from tracheal intubation to injection of neuromuscular reversal agent)	the observed number of restoration of self breathing during the surgery (ex. EtCO2 notching)
Dosage of remifentanil	intraoperative (from starting of anesthesia to end of anesthesia)	the amount of remifentanil used (mcg/kg)
Patient movement	intraoperative (from tracheal intubation to injection of neuromuscular reversal agent)	the observed number of patient movement during the surgery
Surgical condition score	assessed at the end of the surgery	the 5-point satisfaction score of surgeon regarding surgical conditions

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of