Remifentanil and Desflurane Inhalational Anesthesia in Bariatric Surgeries

Phase 2

• Conditions: Anesthesia Emergence
• Interventions: Drug: Remifentanil 0.2 ug/kg; Drug: Normal Saline; Drug: Remifentanil 0.1 ug/kg

• Registration Number: NCT03219788
• Lead Sponsor: Assiut University

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-14
• Last Update Submitted: 2017-07-14
• Study First Posted: 2017-07-18
• Last Update Posted: 2017-07-18
• Study Start: 2017-07-20
• Primary Completion: 2017-11-01
• Study Completion: 2017-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3 ((Remifentanil 0.2 ug/kg))	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 1(Normal saline)	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 2 (Remifentanil 0.1 ug/kg)	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.

Primary Outcome Measures

Name	Time	Method
Changes in hemodynamic	within the first 24 hours	Mean blood pressure and heart rate will be recorded before surgery and combined with all the other study items at the end of surgery, at the extubation time, after 5 minutes in PACU, after 10 minutes in Postanesthesia Care Unit (PACU) and he last registered reading in PACU.
antitussive effect	within the first 24 hours	cough assessment at recovery time 0 no cough; 1. single cough; 2. cough episode less than five seconds or multiple coughs; 3. sustained attack of cough lasts more than five seconds

Secondary Outcome Measures

Name	Time	Method
Respiratory depression	within the first 24 hours	In the postoperative period
Postoperative pain	within the first 24 hours	The duration from extubation till the first painkiller and pain severity using VAS at the extubation time will recorded