Deep Neuromuscular Block and Sugammadex Versus Standard of Care on Quality of Recovery in Patient Undergo Elective Laparoscopic Cholecystectomy

NCT ID: NCT02648503

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-12-31

Brief Summary

Single center, prospective, randomized, single blinded, parallel group and controlled, assessor-blinded trial to compare the impact of Deep neuromuscular block and Sugammadex versus Standard of care on Quality of recovery in patient undergo elective laparoscopic cholecystectomy using PQRS at different time-point: 15 minutes (T15), 40 minutes (T40), one(D1) and three(D3) days after surgery

Detailed Description

• In the current study, the investigators investigate the effect of a deep NMB (TOF 0, PTC 1-2) with sugammadex against a moderate block (TOF 1-2) on quality of recovery in patient undergo elective laparoscopic cholecystectomy using PQRS at different time-point: 15 minutes (T15), 40 minutes (T40), one(D1) and three(D3) days after surgery.
• Based on a previous study comparing the Quality of recovery using PQRS between Neostigmine and Sugammadex, P. Amorim at al. showed that the percentage of patients fully awake at 40 min was 96.2% in the sugammadex group and 72.9% in the neostigmine group; the investigators expected the percentage of patient recovery at T40 will be 90% in group D (sugammadex) and 70% in group M (neostigmine)12. Recovery defined as return to the value of PQRS measured prior to surgery or higher. Using the formula for the sample size with α=0.05, Power: 80%, the sample size required per group is 60.
• Eligible patients will be randomly allocated into two groups using a computer-generated randomization before patients arrive to the operating room: Group D with deep, continuous neuromuscular blockade and Group M with moderate neuromuscular blockade.
• All information about group allocation, doses of rocuronium and sugammadex and neuromuscular data are recorded on a separate form and placed in a sealed opaque envelope when the patient is leaving the operating room. This will keep the personnel in the post-anesthesia care unit and the investigator collecting post-operative data blinded to group allocation.
• The investigators use acceleromyography (TOF-Watch SX) to monitor the level of neuromuscular blockage at the adductor pollicis muscle
• Involuntary movement will be recorded by anesthesia during surgery.
• Surgical condition will be rated by surgeons after surgery using five-point surgical condition scale (SRS)
• Hemodynamic changes using the noninvasive Nihon Konden (Nihon Konden, Japan), duration of surgery, drug dosages used during anesthesia, and duration from reversal to extubation, BIS, and ventilatory variables (tidal volume, respiratory rate, breathing pressure).
• Intra-abdominal pressure will be measured every 15 minutes from the peritoneal CO2 insufflation device. Pneumoperitoneum is obtained with insufflation of CO2 at 8 mmHg after the introduction of the trocars. In case of inadequate surgical conditions:

• Increase of pre-set intra-abdominal pressure to 12-14 mmHg.
• If still not adequate, patients will be given a bolus of rocuronium 0.075-0.15 mg/kg
• If still not adequate, the surgeon will decide according to usual clinical practice.
• The intervention will be recorded by anesthesiologist and surgical condition rate will be measured at the time of surgery when they get worse.
• PQRS includes six domains of recovery: physiologic, nociceptive, emotive, activities of daily living, cognitive, and overall patient perspective. There is a series of questions in each domain2. PQRS data will be presented as percentage of patients that recovered for measurements taken at T15, T40, D1, and D3.
• Data of all patients that completed the baseline evaluation and T15 and T40 of the follow-up evaluations will be included in primary efficacy analysis.
• Continuous data will be presented as mean and standard deviation (SD) or median and range (minimum, maximum) and interquartile range (IQR, 25th 75th percentile). Categorical data will be presented as frequencies and percentages.
• The physiological domain data will be presented as mean and SD. The nociceptive domain data will be presented as mean with the 95% confidence intervals (CI).
• Categorical variables will be compared with the the Fisher exact test.
• For the comparison of continuous data, the Student's t test will be used. If there is substantial evidence of departures from normality, then the Mann-Whitney U-test will be performed as a sensitivity analysis.
• Data will be analyzed with the Statistical Package for the Social Sciences statistical software program. Statistical significance was set at P less than 0.05.

Conditions

Neuromuscular Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Deep neuromuscular block

PTC=1-2

Group Type: EXPERIMENTAL

Deep neuromuscular block

Intervention Type: DRUG

Using rocuronium and reversal with sugammadex

Moderate neuromuscular block

TOF=1-2

Group Type: ACTIVE_COMPARATOR

Moderate neuromuscular block

Intervention Type: DRUG

Using rocuronium and reversal with neostigmine (1 to 2 mg) and atropine (0.5 to 1 mg)

Interventions

Deep neuromuscular block

Using rocuronium and reversal with sugammadex

Intervention Type: DRUG

Moderate neuromuscular block

Using rocuronium and reversal with neostigmine (1 to 2 mg) and atropine (0.5 to 1 mg)

Intervention Type: DRUG

Other Intervention Names

Esmeron and Bridion; Esmeron and Neostigmin/Atropine

Eligibility Criteria

Inclusion Criteria

• All adult patients (> 18 years) scheduled for elective Laparoscopic Cholecystectomy with American Society of Anesthesiologist (ASA) class I-III in Hospital of University of Medicine and Pharmacy-Ho Chi Minh City

Exclusion Criteria

• Patients with ASA class IV
• Age <18 years
• Inability to inform consent
• History or suspected with neuromuscular disorders
• Allergies to rocuronium or sugammadex, anesthetics or narcotics drugs
• A history of malignant hyperthermia
• A contraindication with neostigmine administration
• Pregnancy or breastfeeding
• Renal and liver insufficiency are excluded from this study

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

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role: lead

Responsible Party

Phan Ton Ngoc Vu

PhD. MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vu TN Phan, PhD. MD

Role: PRINCIPAL_INVESTIGATOR

University medical center HCMC

Locations

Operation theathre

Ho Chi Minh City, , Vietnam

Countries

Vietnam

Central Contacts

Vu TN Phan, PhD. MD

Role: CONTACT

vuphan682003@yahoo.com

+84-908883458

Hung HM Phan, MD

Role: CONTACT

phanhaminhhung@gmail.com

+84-938183079

Facility Contacts

Vu TN Phan, PhD. MD

Role: primary

vuphan682003@yahoo.com

+84-90883458

Other Identifiers

8616-138

Identifier Type: -

Identifier Source: org_study_id