Compare of Surgical Condition and Complications With Moderate and Deep NM Block
- Registration Number
- NCT02601508
- Lead Sponsor
- Chonnam National University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- All adult (≥ 20 years of age) patients scheduled for an elective laparoscopic gastrectomy who have signed the written informed consent.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Modarate Blockade Group cis-atracurium Neuromuscular blocking agent, cis-atracurium will be administered after skin incision and reversal agents, pyridostigmine \& glycopyrrolate will be given for the recovery. Deep Blockade Group Rocuronium Neuromuscular blocking agent, rocuronium will be administered after skin incision and reversal agent, Sugammadex will be given for the recovery.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Chonnam University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of