NCT02648503

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

December 7, 2015

Last Update Submit

January 6, 2016

Conditions

Neuromuscular Block

Keywords

SugammadexPost-operative Quality Recovery Scale (PQRS)

Outcome Measures

Primary Outcomes (1)

  • Quality of recovery

    The primary outcome is to access the differences of Quality of recovery in the overall recovery of the Post-operative Quality Recovery Scale (PQRS) instrument at 40 minutes (T40) after the end of surgery between Deep NMB (reversed with Sugammadex) and Standard of care in patients who undergo Laparoscopic Cholecystectomy. 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 domain. The Postoperative Quality Recovery Scale (PQRS) will be performed and recorded face-to-face by anesthesiologists in hospital and by telephone after discharge. The PQRS is completed prior to surgery to provide baseline values. Recovery is defined as returning to baseline values or better in each of the questions or assessments.

    40 minutes (T40) after the end of surgery

Secondary Outcomes (2)

  • Quality of recovery

    15 minutes (T15), and first day, 3 days after the end of surgery

  • Shoulder tip pain

    first hour, 6 hours and 24 hours after surgery

Other Outcomes (3)

  • Surgical condition

    intraoperation

  • Time to discharge readiness

    Every 20 min from the start of admission to the post-anesthesia care unit (PACU), up to 2 hours

  • Duration of operation

    intraoperation

Study Arms (2)

Deep neuromuscular block

EXPERIMENTAL

PTC=1-2

Drug: Deep neuromuscular block

Moderate neuromuscular block

ACTIVE COMPARATOR

TOF=1-2

Drug: Moderate neuromuscular block

Interventions

Deep neuromuscular blockDRUG

Using rocuronium and reversal with sugammadex

Also known as: Esmeron and Bridion
Deep neuromuscular block
Moderate neuromuscular blockDRUG

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

Also known as: Esmeron and Neostigmin/Atropine
Moderate neuromuscular block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Operation theathre

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Interventions

RocuroniumSugammadexAtropine

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compoundsgamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Vu TN Phan, PhD. MD

    University medical center HCMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vu TN Phan, PhD. MD

CONTACT

+84-908883458vuphan682003@yahoo.com

Hung HM Phan, MD

CONTACT

+84-938183079phanhaminhhung@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. MD

Study Record Dates

First Submitted

December 7, 2015

First Posted

January 7, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

January 7, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share

Locations

VN(1)