Clinical trial NCT02601508: Compare of Surgical Condition and Complications With Moderate and Deep NM Block
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuromuscular Blockade
Keywords: deep NM block
Surgeon's satisfaction
bridion
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical rating SCORE(SRS)
timeFrame: every 15 minutes from the pneumoperitoneum, up to 120 minutes till the end of surgery
Secondary outcomes:
measure: Respiratory rate
timeFrame: every 15 minutes from the arrival on the recovery room, up to 60 minutes
measure: peripheral arterial oxygen saturation
timeFrame: every 15 minutes from the arrival on the recovery room, up to 60 minutes
measure: visual analogue scale (VAS) for pain
timeFrame: every 15 minutes from the arrival on the recovery room, up to 60 minutes
measure: occurrence of nausea or vomiting
timeFrame: every 15 minutes from the arrival on the recovery room, up to 60 minutes
measure: the level of sedation or alertness
timeFrame: every 15 minutes from the arrival on the recovery room, up to 60 minutes
measure: Postoperative Quality Recovery Scale (PQRS)
timeFrame: 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
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam University Hwasun Hospital
Study officials:
affiliation: Chonnam University Hospital
name: SEONGWOOK JEONG, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: