Opioid Free Versus Opioid Balanced Anesthesia

NCT03809949 | Completed Phase 4

• 1 other identifier: 050108073(18/12/2018)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

PONV; Opioid Use

Outcome Measures

Primary Outcomes (1)

• PONV

  Post operative nausea and vomiting from 0-3 for nausea and 0 to 4 for vomiting

  72 hours

Secondary Outcomes (3)

• analgesia.post-operative pain

  72 hours

• Patient satisfaction

  72 hours

• Drowsiness

  72 hours

Study Arms (2)

Fentanyl Opioid Anesthesia

ACTIVE COMPARATOR

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

Saline Nonopioid Anesthesia

PLACEBO COMPARATOR

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

Interventions

Fentanyl Opioid anesthesia DRUG

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

Fentanyl Opioid Anesthesia

Saline Nonopioid anesthesia DRUG

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

Saline Nonopioid Anesthesia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21111, Egypt

Location

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MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Doctors, patients and outcomes assessors will be blinded regarding the technique used in anesthesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

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

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 18, 2019
• Study Start: January 16, 2019
• Primary Completion: May 21, 2019
• Study Completion: May 22, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)