Remifentanil and Desflurane Inhalational Anesthesia in Bariatric Surgeries

Study Overview
=================
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

Official Title
-----------------
The Recovery Profile of Different Doses of Remifentanil After Desflurane Inhalational Anesthesia for Bariatric Surgeries: Two Centers Controlled Prospective Study

Conditions
-----------------
Anesthesia Emergence

Intervention / Treatment
-----------------
* Drug: Normal Saline
* Drug: Remifentanil 0.1 ug/kg
* Drug: Remifentanil 0.2 ug/kg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥ 18 years Subject has signed informed consent for bariatric laparoscopic surgery. Subject must be ASA I or ASA II according to the American Society of Anesthetists classification. Exclusion Criteria: Age < 18 years. Smoking patient. Hypertension. Bronchial asthma. Obstructive sleep apnea syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1(Normal saline)<br>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. | Drug: Normal Saline<br>* All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline will be given<br>* Other names: Placebo;|
| Active Comparator: Group 2 (Remifentanil 0.1 ug/kg)<br>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. | Drug: Remifentanil 0.1 ug/kg<br>* All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.1 ug/kg Remifentanil will be given<br>|
| Active Comparator: Group 3 ((Remifentanil 0.2 ug/kg))<br>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. | Drug: Remifentanil 0.2 ug/kg<br>* All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.2 ug/kg Remifentanil will be given<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hemodynamic | 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. | within the first 24 hours | 
| antitussive effect | cough assessment at recovery time 0 no cough single cough cough episode less than five seconds or multiple coughs sustained attack of cough lasts more than five seconds | within the first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory depression | In the postoperative period | within the first 24 hours | 
| Postoperative pain | The duration from extubation till the first painkiller and pain severity using VAS at the extubation time will recorded | within the first 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emergence, remifentanil, recovery, desflurene