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

Neuromuscular Blockade Clinical Trial

— MISPCNUHH  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02601508
• Other study ID #: CNUHH-2015-135
• Status: Not yet recruiting
• Phase: N/A
• First received: November 3, 2015
• Last updated: November 8, 2015
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: November 2015
• Source: Chonnam National University Hospital
• Contact: SEONGHEON LEE, MD, PhD
• Phone: +82-10-8612-9548
• Email: headheadhead[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Blockade
• Postoperative Complications

Intervention

Drug:
• Rocuronium
Continuous infusion of rocuronium for PTC 1 + Sugammadex
• cis-atracurium
Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine & Glycopyrrolate

Locations

Country	Name	City	State
Korea, Republic of	Chonnam University Hwasun Hospital	Hwasun

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Respiratory rate	Respiratory rate of patient	every 15 minutes from the arrival on the recovery room, up to 60 minutes	Yes
Secondary	peripheral arterial oxygen saturation	peripheral arterial oxygen saturation(sPO2)	every 15 minutes from the arrival on the recovery room, up to 60 minutes	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes