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

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

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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia; Laparoscopy; Neuromuscular Blockade
• Intervention / Treatment: Drug: Rocuronium: PTC(Post-tetanic count) 1~2; Drug: Rocuronium: TOF(Train-of-four) 1~2

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group D; Deep neuromuscular blockade	Drug: Rocuronium: PTC(Post-tetanic count) 1~2; Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.; Other Names: Deep block
Active Comparator: Group M; Moderate neuromuscular blockade	Drug: Rocuronium: TOF(Train-of-four) 1~2; Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.; Other Names: Moderate block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of propofol	the amount of propofol used (mg/kg)	intraoperative (from starting of anesthesia to end of anesthesia)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Study Chair: Ah Young Oh, MD, PhD, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Nam SW, Oh AY, Koo BW, Kim BY, Han J, Chung SH. Effects of depth of neuromuscular blockade on the BIS-guided propofol requirement: A randomized controlled trial. Medicine (Baltimore). 2021 Jul 23;100(29):e26576. doi: 10.1097/MD.0000000000026576.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Deep neuromuscular blockade
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: DEEPTIVA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No