Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890406
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
BON WOOK KOO, 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.

Condition or disease Intervention/treatment Phase
Laparoscopy General Anesthesia Neuromuscular Blockade Drug: Rocuronium: PTC(Post-tetanic count) 1~2 Drug: Rocuronium: TOF(Train-of-four) 1~2 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Deep Neuromuscular Blockade on Requirement of Intravenous Anesthetic Agent During Laparoscopic Colorectal Surgery
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Moderate block




Primary Outcome Measures :
  1. Dosage of propofol [ Time Frame: intraoperative (from starting of anesthesia to end of anesthesia) ]
    the amount of propofol used (mg/kg)


Secondary Outcome Measures :
  1. Dosage of remifentanil [ Time Frame: intraoperative (from starting of anesthesia to end of anesthesia) ]
    the amount of remifentanil used (mcg/kg)

  2. Patient movement [ Time Frame: intraoperative (from tracheal intubation to injection of neuromuscular reversal agent) ]
    the observed number of patient movement during the surgery

  3. Patient self respiration [ Time Frame: intraoperative (from tracheal intubation to injection of neuromuscular reversal agent) ]
    the observed number of restoration of self breathing during the surgery (ex. EtCO2 notching)

  4. Surgical condition score [ Time Frame: assessed at the end of the surgery ]
    the 5-point satisfaction score of surgeon regarding surgical conditions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890406


Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Layout table for investigator information
Study Chair: Ah Young Oh, MD, PhD Seoul National University Bundang Hospital
Layout table for additonal information
Responsible Party: BON WOOK KOO, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03890406    
Other Study ID Numbers: DEEPTIVA
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BON WOOK KOO, Seoul National University Bundang Hospital:
Deep neuromuscular blockade
Additional relevant MeSH terms:
Layout table for MeSH terms
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs