Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients

NCT ID: NCT02553629

Last Updated: 2017-02-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-04-30

Brief Summary

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This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.

Detailed Description

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Conditions

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Surgical Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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moderate neuromuscular block

rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches

Group Type ACTIVE_COMPARATOR

Rocuronium

Intervention Type DRUG

deep neuromuscular block

rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches

Group Type EXPERIMENTAL

Rocuronium

Intervention Type DRUG

Interventions

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Rocuronium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA I-III
* BMI \> 34 kg/m2
* Elective bariatric surgery.

Exclusion Criteria

* Known or suspected neuromuscular disorders impairing neuromuscular function
* Allergies to muscle relaxants, anesthetics or narcotics
* A(family) history of malignant hyperthermia
* Women who are or may be pregnant or are currently breast feeding
* Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output \< 0.5 ml/kg/h for at least 6 h.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Medical Center Haaglanden

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Albert Dahan

MD, PhD, professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Albert Dahan, MD, PhD, professor

Role: PRINCIPAL_INVESTIGATOR

LUMC

Locations

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Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status

Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek

The Hague, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL52829.058.15

Identifier Type: -

Identifier Source: org_study_id

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