Remifentanil and Desflurane Inhalational Anesthesia in Bariatric Surgeries

Anesthesia Emergence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03219788
• Other study ID #: IRB00008715892
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 5, 2017
• Last updated: July 14, 2017
• Start date: July 20, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: Mohamed S Ali, MD
• Phone: 0020882413201
• Email: msali58[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia Emergence

Intervention

Drug:
• Normal Saline
All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline will be given
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Respiratory depression	In the postoperative period	within the first 24 hours
Secondary	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