Neuromuscular Blockade
Conditions
Keywords
deep NM block, Surgeon's satisfaction, bridion
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.
Interventions
DRUGRocuronium
Continuous infusion of rocuronium for PTC 1 + Sugammadex
DRUGcis-atracurium
Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine & Glycopyrrolate
Sponsors
Chonnam National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Respiratory rate | every 15 minutes from the arrival on the recovery room, up to 60 minutes | Respiratory rate of patient |
| 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 |
| 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 |
Countries
South Korea
Contacts
Primary ContactSEONGHEON LEE, MD, PhD
Backup ContactShiyoung JEONG, MD
Outcome results
None listed