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Opioid Free Versus Opioid Balanced Anesthesia

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ClinicalTrials.gov Identifier: NCT03809949
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammad Hazem I. Ahmad Sabry, University of Alexandria

Brief Summary:

OPIOID FREE VERSUS OPIOID BALANCED ANAESTHESIA IN MIDDLE EAR SURGERY AIM OF THE WORK

Primary aim:

To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery

Secondary aim:

Monitoring analgesia, post-operative satisfaction and drowsiness.


Condition or disease Intervention/treatment Phase
PONV Opioid Use Drug: Fentanyl Opioid anesthesia Drug: Saline Nonopioid anesthesia Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Doctors, patients and outcomes assessors will be blinded regarding the technique used in anesthesia.
Primary Purpose: Treatment
Official Title: Opioid Free Versus Opioid Balanced Anesthesia in Middle Ear Surgery.
Actual Study Start Date : January 16, 2019
Actual Primary Completion Date : May 21, 2019
Actual Study Completion Date : May 22, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl

Arm Intervention/treatment
Active Comparator: Fentanyl Opioid Anesthesia
Fentanyl (1mg/kg i.v.) will be administered before general anaesthesia (GA). GA will be maintained with inhalation anaesthetics (isoflurane) at a minimum alveolar concentration of 0.7-1.3.
Drug: Fentanyl Opioid anesthesia
To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery

Placebo Comparator: Saline Nonopioid Anesthesia
Opioid free anesthesia (syringe of saline is given instead of fentanyl) and the same general anesthesia is given as group A(muscle relaxant ,propofol, inhalation for maintance).
Drug: Saline Nonopioid anesthesia
To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery




Primary Outcome Measures :
  1. PONV [ Time Frame: 72 hours ]
    Post operative nausea and vomiting from 0-3 for nausea and 0 to 4 for vomiting


Secondary Outcome Measures :
  1. analgesia.post-operative pain [ Time Frame: 72 hours ]
    analgesia, post-operative VAS score

  2. Patient satisfaction [ Time Frame: 72 hours ]
    satisfaction degree by QoR40 questionnaire from 40 to 200

  3. Drowsiness [ Time Frame: 72 hours ]
    Drowsiness scores by RAMSY sedation score from 0 to 4



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of either sex.
  • American Society Anesthesiologists' physical status I-II.
  • Age between 18 and 50 years.

Exclusion Criteria:

  • Patients with gastrointestinal disease.
  • A history of motion sickness, or a previous episode of PONV.
  • Patient received any opioid, steroid, or antiemetic medication within 72 h before surgery.
  • Those who were pregnant or menstruating.
  • History of opioid or drug abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809949


Locations
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Egypt
Alexandria Faculty of Medicine
Alexandria, Egypt, 21111
Sponsors and Collaborators
University of Alexandria

Publications:
Quemby DJ. Day surgery development and practice: key factors for a successful pathway. CEACCP 2014;14: 256-61.
Moore KL, Dalley AF. Clinically orientated anatomy. 4th ed. Philadelphia: Lippinocott Williams & Wilkins; 1999.
Dhillon RS, East CA. Ear, nose, throat, and head and neck surgery: an illustrated colored text. 2nd ed. New York, Edinburgh: Churchill Livingstone;1999
Miller RD. Miller's anesthesia, 6th ed. Vol 2. New York: Elsevier/Churchill Livingstone; 2005.
Morgan EG, Mikhail MS, Murray MJ. Clinical anesthesiology. 4th ed. New York: Lange Medical Books/McGraw-Hill; 2006.
Shakir AAK, Ramachandra V, Hasan MA. Day surgery postoperative nausea and vomiting at home related to preoperative fentanyl. J One-day Surg 1997;6:10-1.
Vandermeulen EP. Controlling the stress response. In: White PF (ed). Textbook of Intravenous Anesthesia. Baltimore: Williams & Wilkins; 1997. p. 565-79.
Gan TJ, Glass PSA. Balanced anesthesia. In: White PF (ed). Textbook of Intravenous Anesthesia. Baltimore: Williams & Wilkins; 1997. p. 347-74.
Smith I. Inhalational anesthetic agents. In: Hemmings HC, Hopkins PM (eds). Foundations of Anesthesia. 2nd ed. London: Elsevier; 2005. p. 311-21.

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Responsible Party: Mohammad Hazem I. Ahmad Sabry, Lecturer of Anesthesia, University of Alexandria
ClinicalTrials.gov Identifier: NCT03809949     History of Changes
Other Study ID Numbers: 050108073(18/12/2018)
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fentanyl
Analgesics, Opioid
Analgesics, Non-Narcotic
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General