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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890406
• Other study ID #: DEEPTIVA
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2020
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Laparoscopy
• Neuromuscular Blockade

Intervention

Drug:
• Rocuronium: PTC(Post-tetanic count) 1~2
Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.
• Rocuronium: TOF(Train-of-four) 1~2
Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of propofol	the amount of propofol used (mg/kg)	intraoperative (from starting of anesthesia to end of anesthesia)
Secondary	Dosage of remifentanil	the amount of remifentanil used (mcg/kg)	intraoperative (from starting of anesthesia to end of anesthesia)
Secondary	Patient movement	the observed number of patient movement during the surgery	intraoperative (from tracheal intubation to injection of neuromuscular reversal agent)
Secondary	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)
Secondary	Surgical condition score	the 5-point satisfaction score of surgeon regarding surgical conditions	assessed at the end of the surgery