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

Sponsor

Chonnam National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02601508

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Blockade	Drug: Rocuronium Drug: cis-atracurium	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2016

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

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®

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®

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Respiratory rate [every 15 minutes from the arrival on the recovery room, up to 60 minutes]
Respiratory rate of patient
peripheral arterial oxygen saturation [every 15 minutes from the arrival on the recovery room, up to 60 minutes]
peripheral arterial oxygen saturation(sPO2)
visual analogue scale (VAS) for pain [every 15 minutes from the arrival on the recovery room, up to 60 minutes]
visual analogue scale (VAS) for pain
occurrence of nausea or vomiting [every 15 minutes from the arrival on the recovery room, up to 60 minutes]
occurrence of nausea or vomiting with Rhodes Index
the level of sedation or alertness [every 15 minutes from the arrival on the recovery room, up to 60 minutes]
the level of sedation or alertness with OAA/S scale
Postoperative Quality Recovery Scale (PQRS) [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]
physiologic, nociceptive, emotive, cognitive and activities of daily living

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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