Respiratory Mechanics and Metabolic Changes During Low Pr... | NCT02469831

Studies
Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy

NCT02469831

Sponsor

Assiut University

Status

Completed

Last Update Posted

Mar 28, 2017Actual

Enrollment

40Actual

Phase

Phase 2

Conditions

Laparoscopic Cholecystectomy

Interventions

Rocuronium

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

May 24, 2015

First Submission Date that Met QC Criteria

Jun 11, 2015

First Posted Date

Jun 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2017

Last Update Posted Date

Mar 28, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rocuronium	Drug		group D group I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
respiratory mechanics (Dynamic compliance)	Dynamic compliance	intraoperative

Secondary Outcomes

Measure	Description	Time Frame
surgeon satisfaction (scale from 1 to 5)	scale from 1 to 5	intraoperative
postoperative pain (VAS score)	VAS score	postoperative for 6 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

more than 18 years
undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Osama ibraheim, MD	Assiut University	Study Chair
MOSTAFA ABBAS, MD	Assiut University	Study Chair
AHMED TAHA, MD	Assiut University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al Rajhy liver hospital		Asyut	Asyut Governorate	71515	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D000077123	Rocuronium

Ancestor Terms

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided