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Remifentanil and Desflurane Inhalational Anesthesia in Bariatric Surgeries

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03219788
Collaborator
(none)
120
Enrollment
3
Arms
3.4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Normal Saline
  • Drug: Remifentanil 0.1 ug/kg
  • Drug: Remifentanil 0.2 ug/kg
 Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Recovery Profile of Different Doses of Remifentanil After Desflurane Inhalational Anesthesia for Bariatric Surgeries: Two Centers Controlled Prospective Study
Anticipated Study Start Date :
Jul 20, 2017
Anticipated Primary Completion Date :
Nov 1, 2017
Anticipated Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 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.

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

    		•
    Active Comparator: 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.

    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
    Active Comparator: 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.

    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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. antitussive effect [within the first 24 hours]

      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

    Secondary Outcome Measures

    1. Respiratory depression [within the first 24 hours]

      In the postoperative period

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Ageā‰„ 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Mohamed S Ali, MD, Associate profossor of anesthesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Mohamed Shaaban Ali, PhD, MD, Associate Profossor of Anesthesiology, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03219788
    Other Study ID Numbers:
    • IRB00008715892
    First Posted:
    Jul 18, 2017
    Last Update Posted:
    Jul 18, 2017
    Last Verified:
    Jul 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr Mohamed Shaaban Ali, PhD, MD, Associate Profossor of Anesthesiology, Assiut University
    emergence
    remifentanil
    recovery
    desflurene
    Additional relevant MeSH terms:
    Remifentanil

    Study Results

    No Results Posted as of Jul 18, 2017