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

NCT ID: NCT03890406

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-03-31

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.

Conditions

Laparoscopy; General Anesthesia; Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group D

Deep neuromuscular blockade

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Group M

Moderate neuromuscular blockade

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Other Intervention Names

Deep block; Moderate block

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

BON WOOK KOO

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ah Young Oh, MD, PhD

Role: STUDY_CHAIR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 34398011 (View on PubMed)

Other Identifiers

DEEPTIVA

Identifier Type: -

Identifier Source: org_study_id