Remifentanil and Desflurane Inhalational Anesthesia in Bariatric Surgeries

NCT03219788 | Unknown Phase 2 DMC

• 1 other identifier: IRB00008715892
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia Emergence

Keywords

emergence; remifentanil; recovery; desflurene

Outcome Measures

Primary Outcomes (2)

• 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 1. single cough 2. cough episode less than five seconds or multiple coughs 3. sustained attack of cough lasts more than five seconds

  within the first 24 hours

Secondary Outcomes (2)

• Respiratory depression

  within the first 24 hours

• Postoperative pain

  within the first 24 hours

Study Arms (3)

Group 1(Normal saline)

PLACEBO COMPARATOR

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

Group 2 (Remifentanil 0.1 ug/kg)

ACTIVE COMPARATOR

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

Group 3 ((Remifentanil 0.2 ug/kg))

ACTIVE COMPARATOR

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

Interventions

Normal Saline DRUG

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

Also known as: Placebo

Group 1(Normal saline)

Remifentanil 0.1 ug/kg 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 2 (Remifentanil 0.1 ug/kg)

Remifentanil 0.2 ug/kg 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

Group 3 ((Remifentanil 0.2 ug/kg))

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years.
• Smoking patient.
• Hypertension.
• Bronchial asthma.
• Obstructive sleep apnea syndrome.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Saline Solution; Remifentanil

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohamed S Ali, MD

  Associate profossor of anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed S Ali, MD

CONTACT

0020882413201; msali58@hotmail.com

Sayed K Abd-Elshafy, MD

CONTACT

0020882413201; sayed_k_72@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profossor of Anesthesiology

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 18, 2017
• Study Start: July 20, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-07