NCT02469831

Brief Summary

The investigators aim to investigate the differences between deep continuous muscle relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in respect to metabolic changes and respiratory mechanics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

May 24, 2015

Last Update Submit

March 25, 2017

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • respiratory mechanics (Dynamic compliance)

    Dynamic compliance

    intraoperative

Secondary Outcomes (5)

  • surgeon satisfaction (scale from 1 to 5)

    intraoperative

  • postoperative pain (VAS score)

    postoperative for 6 hours

  • postoperative nausea and vomiting

    postoperative for 6 hours

  • completion of surgical procedure

    intraoperative

  • metabolic changes (blood lactate)

    intraoperative

Study Arms (2)

group D

ACTIVE COMPARATOR

deep neuromuscular block by rocuronium defined :post tetanic (PTC) \>1 but no response to a train of four (TOF) stimulation.

Drug: Rocuronium

group I

ACTIVE COMPARATOR

intermediate neuromuscular block by rocuronium defined as TOF count of 1-3.

Drug: Rocuronium

Interventions

RocuroniumDRUG
group Dgroup I

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • more than 18 years
  • undergoing elective laparoscopic cholecystectomy

You may not qualify if:

  • previous surgeries,
  • a history of venous or arterial diseases,
  • BMI (≥30 kg/m2),
  • Allergy to rocuronium.
  • Significant liver dysfunction.
  • Significant renal dysfunction (S-creatinine \> 200 umol/l).
  • Neuromuscular disease that might impair neuromuscular blockade
  • Pregnant or breastfeeding.
  • Indication for rapid sequence induction.
  • Inability to informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Rajhy liver hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Osama ibraheim, MD

    Assiut University

    STUDY CHAIR

  • MOSTAFA ABBAS, MD

    Assiut University

    STUDY CHAIR

  • AHMED TAHA, MD

    Assiut University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia and ICU

Study Record Dates

First Submitted

May 24, 2015

First Posted

June 12, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

EG(1)