Compare of Surgical Condition and Complications With Moderate and Deep NM Block (MISPCNUHH)

A Randomized, Parallel Design, Single-center Study to Compare of Surgical Condition and Postoperative Complications With Moderate and Deep Neuromuscular Blockade in Laparoscopic Gastrectomy

This study is designed to evaluate the surgeon's satisfaction with either deep or moderate neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery profiles in the recovery room and the ward.The explorative objective of this study is to evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of postoperative complications.

Study Overview

• Status: Unknown
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Drug: cis-atracurium; Drug: Rocuronium

Detailed Description

Neuromuscular blocking agents (NMBAs) are frequently using during anesthesia to facilitate tracheal intubation and to improve surgical conditions. In an adequately anesthetized and monitored patient, the presence of one or two responses in the train-of-four (TOF) pattern normally indicates sufficient relaxation for most surgical procedures in general practices. It has been called moderate neuromuscular blockade (mNMB) condition. Nowadays, laparoscopic surgeries have expanded impressively into various areas of surgeries, both in scope and volume. If any hypothetical advantages of deep neuromuscular blockade (dNMB) during laparoscopic surgery turned out to be realized in practice with sufficient supporting evidence, it would become an important anesthetic option for better patient outcomes.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Hwasun, Korea, Republic of, 519-763
    • Chonnam University Hwasun Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All adult (≥ 20 years of age) patients scheduled for an elective laparoscopic gastrectomy who have signed the written informed consent.

Exclusion Criteria:

• Known allergy to rocuronuim, cisatracurium or sugammadex
• Significant liver or kidney dysfunction
• Any neuromuscular disease
• Pregnant or breast feeding
• Indication for rapid sequence induction
• Inability to give informed consent
• Patients taking any medication with potential interference with neuromuscular transmission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Modarate Blockade Group; Neuromuscular blocking agent, cis-atracurium will be administered after skin incision and reversal agents, pyridostigmine & glycopyrrolate will be given for the recovery.	Drug: cis-atracurium; Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine & Glycopyrrolate; Other Names: Nimbex®
Experimental: Deep Blockade Group; Neuromuscular blocking agent, rocuronium will be administered after skin incision and reversal agent, Sugammadex will be given for the recovery.	Drug: Rocuronium; Continuous infusion of rocuronium for PTC 1 + Sugammadex; Other Names: Esmeron®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical rating SCORE(SRS)	excellent (5), good but not optimal (4), moderate (3), poor but acceptable (2) or poor and unacceptable (1)	every 15 minutes from the pneumoperitoneum, up to 120 minutes till the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate	Respiratory rate of patient	every 15 minutes from the arrival on the recovery room, up to 60 minutes
peripheral arterial oxygen saturation	peripheral arterial oxygen saturation(sPO2)	every 15 minutes from the arrival on the recovery room, up to 60 minutes
visual analogue scale (VAS) for pain	visual analogue scale (VAS) for pain	every 15 minutes from the arrival on the recovery room, up to 60 minutes
occurrence of nausea or vomiting	occurrence of nausea or vomiting with Rhodes Index	every 15 minutes from the arrival on the recovery room, up to 60 minutes
the level of sedation or alertness	the level of sedation or alertness with OAA/S scale	every 15 minutes from the arrival on the recovery room, up to 60 minutes
Postoperative Quality Recovery Scale (PQRS)	physiologic, nociceptive, emotive, cognitive and activities of daily living	at baseline (the day before surgery), at 1 hour after surgery, at 6 hours after surgery, at 24 hours after surgery and at 7 days after surgery

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Investigators: Principal Investigator: SEONGWOOK JEONG, MD, PhD., Chonnam University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 8, 2015
• First Posted (Estimate): November 10, 2015

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 8, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: deep NM block; Surgeon's satisfaction; bridion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium; Cisatracurium; Atracurium
• Other Study ID Numbers: CNUHH-2015-135