The Effect of Deep Neuromuscular Block on Surgical Condition During Laparoscopic Colorectal Surgery

NCT ID: NCT02580188

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-24
• Study Completion Date: 2016-06-18

Brief Summary

This study is a randomized, controlled, double-blinded, and parallel design study. A total 96 patients were randomized to receive a deep block or a moderate block scheduled for elective laparoscopic colorectal surgery. Investigators estimated the proportion of intra-abdominal pressure(IAP) alarm and surgical rating score.

Detailed Description

Patients >18 years of age with an america society of anesthesiologist classification of I or II who were scheduled to undergo elective laparoscopic colorectal surgery were included. The exclusion criteria were a history of neuromuscular, renal, or hepatic disease, a history of low abdominal surgery; treatment with drugs known to interfere with neuromuscular function. Patients were randomised to either the moderate or deep neuromuscular blockade group using Random Allocation Software (version 1.0). Premedication with intravenous midazolam at 0.03 mg/kg was performed in the reception area. In the operating room, routine monitoring was performed, including electrocardiography, non-invasive arterial pressure measurements, and pulse oximetry. Additionally, acceleromyography was applied to monitor the response of the corrugator supercilii muscle. Neuromuscular management and monitoring were performed according to the Good Clinical Research Practice guidelines. After the induction of anaesthesia with propofol and remifentanil using target-controlled infusers and before rocuronium administration, the TOF-Watch-SX was calibrated and stabilised; a 50-Hz tetanic stimulation was applied for 5 s, the TOF-Watch-SX was calibrated, and a series of train-of-four (TOF) measurements were documented for >2 min until a stable baseline was obtained (<5% variation in the TOF ratios). Next, intravenous rocuronium at 0.6 mg/kg was administered, and tracheal intubation was performed after confirmation of relaxation. Anesthesia was maintained with desflurane and target-controlled infusion of remifentanil while monitoring the bispectral index. A continuous dose of intravenous rocuronium (10-60 mg/hr) was used to maintain moderate (TOF count of 1 or 2) or deep (post-tetanic count [PTC] of 1 or 2) neuromuscular blockade. The IAP alarm(IAP>15mmHg) rate were checked. Any movement during the operation as reported by the surgeon or anaesthesiologist was recorded. At the end of the operation, the surgeon rated the surgical condition on a 5-point scale. Patients in the moderate group were reversed with neostigmine at 50 µg/kg and glycopyrrolate at 10 µg/kg at a TOF count of 1 or 2, and patients in the deep group were reversed with intravenous sugammadex at 4 mg/kg at PTC of 1 or 2. The time from administration of the reversal agents to a TOF ratio of 0.9 was recorded. Postoperative pain and opioid consumption were evaluated at 24, 48h postoperatively. Postoperative nausea and/or vomiting, dry mouth, were also evaluated at the same time points.

Conditions

Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Moderate block

Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Deep block

Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).

Interventions

sugammadex

Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).

Intervention Type: DRUG

Other Intervention Names

deep block

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists grade 1 or 2
• Scheduled for elective laparoscopic Colorectal surgery

Exclusion Criteria

• Severe respiratory or cardiac disease
• Severe hepatic or renal function impairment
• On medications affecting neuromuscular function
• Known allergy to the drugs to be used
• Pregnant
• Malignant hyperthernia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

BON WOOK KOO

assistant proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ah-Young Oh, MD.,Ph.D.

Role: STUDY_CHAIR

Seoul national univ. BUNDANG hospital

Other Identifiers

DNMBC-SNUBH

Identifier Type: -

Identifier Source: org_study_id