Remifentanil and Desflurane Inhalational Anesthesia in Bariatric Surgeries

NCT ID: NCT03219788

Last Updated: 2017-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-20

Study Completion Date

2017-11-01

Brief Summary

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The number of obese and overweighted persons doubled since 1980. They are 600 million in 2014 all over the world. Obesity results in anatomical, physiological and pharmacological changes which represent a challenge for every anesthetist. Difficult airway increases by 30% with obesity and so awake extubation are the preferred technique. Coughing can be alleviated by opioid receptors which play a role in the cough reflex. Remifentanil may be useful as an ultra-short acting opioid and its effect swiftly and predictably disappears after cessation. An emergence cough is attenuated by remifentanil administered via continuous infusion (TCI), and the expected effective effect-site concentrations investigated have ranged from 1.5 to 2.5 ng.ml/L.

Detailed Description

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The investigators designed this study to examine the effect of different small doses of Remifentanil on the incidence of cough reflex during emergence from anesthesia in obese patients undergoing bariatric surgery. The investigators will study if these small doses will delay the recovery of the patient or not. The other expected side effects will be observed eg. Respiratory depression. Time to the first painkiller required will be registered

Conditions

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Anesthesia Emergence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group 1(Normal saline)

Patients who will receive placebo (one ml normal saline). The drug will be given after closure of desflurane at an exhaled MAC of 0.3.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline will be given

Group 2 (Remifentanil 0.1 ug/kg)

Patients who will receive remifentanil at a dose of 0.1 ug/kg. The drug will be given after closure of desflurane at an exhaled MAC of 0.3.

Group Type ACTIVE_COMPARATOR

Remifentanil 0.1 ug/kg

Intervention Type DRUG

All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.1 ug/kg Remifentanil will be given

Group 3 ((Remifentanil 0.2 ug/kg))

Patients who will receive remifentanil at a dose of 0.2 ug/kg. The drug will be given after closure of desflurane at an exhaled MAC of 0.3.

Group Type ACTIVE_COMPARATOR

Remifentanil 0.2 ug/kg

Intervention Type DRUG

All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.2 ug/kg Remifentanil will be given

Interventions

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Normal Saline

All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline will be given

Intervention Type DRUG

Remifentanil 0.1 ug/kg

All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.1 ug/kg Remifentanil will be given

Intervention Type DRUG

Remifentanil 0.2 ug/kg

All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.2 ug/kg Remifentanil will be given

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

1. Age≄ 18 years
2. Subject has signed informed consent for bariatric laparoscopic surgery.
3. Subject must be ASA I or ASA II according to the American Society of Anesthetists classification.

Exclusion Criteria

1. Age \< 18 years.
2. Smoking patient.
3. Hypertension.
4. Bronchial asthma.
5. Obstructive sleep apnea syndrome.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Dr Mohamed Shaaban Ali, PhD, MD

Associate Profossor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed S Ali, MD

Role: PRINCIPAL_INVESTIGATOR

Associate profossor of anesthesiology

Central Contacts

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Mohamed S Ali, MD

Role: CONTACT

0020882413201

Sayed K Abd-Elshafy, MD

Role: CONTACT

0020882413201

Other Identifiers

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IRB00008715892

Identifier Type: -

Identifier Source: org_study_id

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