Effectiveness of Deep Versus Moderate Neuromuscular Blockade

NCT03266419 | Completed Results

• 1 other identifier: 2017-0966
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the influence of depth of neuromuscular blockade during laparoscopic gastrectomy on postoperative pain in surgical patients allocated randomly to either deep or moderate neuromuscular blockade group with standard-pressure pneumoperitoneum of 13 mmHg.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU)

  The patient was administered intravenous oxycodone 2 mg (body weight \<80 kg) or 3 mg (\>80 kg) every 10 min until the VAS (visual analogue scale)assessments showed that the pain intensity had decreased to \<3 at rest and \<5 on wound compression. At this point, MEAD of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).

  Through study period in PACU (post anesthesia care unit), up to 2 hours

Secondary Outcomes (1)

• Mean Visual Analogue Scale (VAS) Score for Wound Pain at Post Anesthesia Care Unit (PACU)

  Through study period in post anesthesia care unit (PACU), an average of about 1 hour

Study Arms (2)

Deep NMB using rocuronium

EXPERIMENTAL

The abdomen is insufflated to 13 mmHg pneumoperitoneum with deep NMB (post tetanic count 1-2) during operation

Drug: Deep NMB using rocuronium

Moderate NMB using rocuronium

ACTIVE COMPARATOR

The abdomen is insufflated to 13 mmHg pneumoperitoneum with moderate NMB (train of four 1-2) during operation

Drug: Moderate NMB using rocuronium

Interventions

Deep NMB using rocuronium DRUG

* Drug: rocuronium * Bolus dose: 0.7 mg/kg * Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.

Deep NMB using rocuronium

Moderate NMB using rocuronium DRUG

* Drug: rocuronium * Bolus dose: none * Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.

Moderate NMB using rocuronium

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 20 to 65 years old
• American Society of Anesthesiologist Physical Status 1, 2 or 3
• Patients undergoing laparoscopic gastrectomy
• Patients who signed a written informed consent form

You may not qualify if:

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
• Patients with known hypersensitivity to rocuronium or sugammadex
• Patient with VAS score (0=no pain; 100=the most severe pain) of at least 10 before surgery
• Patients with liver cirrhosis confirmed by abdominal CT
• Patients with neuromuscular disease that may interfere with neuromuscular data (ex. Duchenne muscular dystrophy, myasthenia gravis)
• Clinically significant impairment of cardiovascular function, defined by ejection fraction \< 50%
• Clinically significant impairment of renal function, defined by estimated GFR \< 60 ml/min or need for hemodialysis
• Clinically significant impairment of liver function, defined by alanine aminotransferase \> 100 IU/L
• Indication for rapid sequence induction
• Use of opioids within the 7 days prior to surgery
• History of abdominal surgery
• History of chronic obstructive pulmonary disease
• Body mass index (BMI) ≥ 35 kg/m2
• Body weight \< 50 kg
• Conversion to laparotomy

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

• Choi BM, Ki SH, Lee YH, Gong CS, Kim HS, Lee IS, Kim BS, Kim BS, Noh GJ. Effects of depth of neuromuscular block on postoperative pain during laparoscopic gastrectomy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Nov;36(11):863-870. doi: 10.1097/EJA.0000000000001082.

  PMID: 31503037 DERIVED

Limitations and Caveats

Pain assessment was performed only until 24 h after the end of surgery.

Results Point of Contact

• Title: Dr. Byung-Moon Choi
• Organization: Asan Medical Center

byungmoonchoi7@gmail.com

82-2-3010-1704

Study Officials

• Byung-Moon Choi, Dr

  Department of Anesthesiology and Pain Medicine, Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Researchers who evaluate postoperative pain will be blinded to the patient's allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor

Model Details: This study is investigator-initiated, randomized, double blinded clinical trial.

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 30, 2017
• Study Start: March 28, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 2, 2018
• Last Updated: November 13, 2019
• Results First Posted: November 13, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)