The Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy

NCT02100280 | Completed Phase 4 Results DMC

• 1 other identifier: SNUBH-NMB
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicenter, randomized, controlled, double-blinded, and parallel design study. A total of 96 patients were decided to be recruited considering a 10% dropout rate. Patients are randomized to receive a deep block or a moderate block. The randomization numbers are generated using a computer-generated randomization code (1) and are sealed in the opaque envelope until they are handed over to the anesthesiologist in charge of anesthesia management after the induction of anesthesia. Patients, surgeons reporting the scale of surgical status, and another researcher analysing the cytokines levels are blinded to the patient group. Patients aged 18-65 yr, ASA 1 or 2, and are scheduled for elective laparoscopic gastrectomy are included. Patients with severe respiratory or cardiac disease, hepatic or renal function impairment, on medications affecting neuromuscular function, and with known allergy to the drugs to be used are excluded.

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular blockade; Sugammadex; Laparoscopic surgery; IL-6

Outcome Measures

Primary Outcomes (1)

• IL-6

  Blood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 6.

  1 hr after the end of operation

Secondary Outcomes (4)

• TNF-α

  30min before end of operation

• IL-1β

  30min before end of operation

• IL-8

  1 hr after end of operation

• CRP

  48 hr after end of operation

Study Arms (2)

deep block

EXPERIMENTAL

After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block.

Drug: deep block

moderate block

NO INTERVENTION

After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.

Interventions

deep block DRUG

sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block

Also known as: bridion

deep block

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists grade 1 or 2
• Scheduled for elective laparoscopic gastrectomy

You may not qualify if:

• Severe respiratory or cardiac disease
• Severe hepatic or renal function impairment
• On medications affecting neuromuscular function
• Known allergy to the drugs to be used

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Bon-wook Koo
• Organization: SNUBH

tendong2@gmail.com

+82-10-7227-1379

Study Officials

• Ah-Young Oh, MD.,Ph.D.

  Seoul national univ. BUNDANG hospital

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 23, 2014
• First Posted: March 31, 2014
• Study Start: June 29, 2014
• Primary Completion: June 14, 2017
• Study Completion: June 16, 2017
• Last Updated: January 10, 2024
• Results First Posted: May 21, 2018

Record last verified: 2024-01