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the Effect of Three Different Analgesic Techniques on the Incidence of Postoperative Nausea and Vomiting

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03313479
Collaborator
(none)
75
Enrollment
1
Location
2.1
Anticipated Duration (Months)
36.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postoperative nausea and vomiting (PONV) is a distressing adverse effect that may result in postoperative complications including bleeding, wound dehiscence, aspiration pneumonitis, as well as fluid and electrolyte imbalances Incidence of PONV after general anesthesia is about 30% in all post-surgical patients but up to 80% in high-risk patients despite advances in anesthetics and anesthesia techniques

Condition or Disease Intervention/Treatment Phase

Detailed Description

Postoperative nausea and vomiting (PONV) is a distressing adverse effect that may result in postoperative complications including bleeding, wound dehiscence, aspiration pneumonitis, as well as fluid and electrolyte imbalances.

The incidence of PONV after general anesthesia is about 30% in all post-surgical patients but up to 80% in high-risk patients despite advances in anesthetics and anesthesia techniques.

Despite new antiemetic drugs the overall incidences remain high especially in subjects with increased patient-related risk-factors such as in female gender, non-smoking status, a history of motion sickness or previous PONV, inhalational anesthetics, certain types of surgery, and opioid use. Scleral buckling (SB) which is still thought to be the most efficacious and cost-effective primary procedure for the treatment of uncomplicated retinal detachment is often associated with postoperative pain as well as nausea and vomiting. Preoperative injections of local anesthetics via retrobulbar, peribulbar, or subtenon routes in patients undergoing vitreoretinal surgery under general anesthesia (GA) have been reported to reduce postoperative pain, nausea, and vomiting.

Topical lidocaine drops have also has been used intraoperatively to decrease the incidence and severity of the OCR and to prevent pain and PONV after strabismus surgery and vitrectomy without scleral buckling .

The current study was designed to compare the effect of three different analgesic techniques ; IV analgesia , peribulbar block and topical xylocaine jel on the incidence of ponv after scleral buckling under general anesthesia.

Study Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparative Study of the Effect of Three Different Analgesic Techniques on the Incidence of Postoperative Nausea and Vomiting After Scleral Buckling Under General Anesthesia
Anticipated Study Start Date :
Oct 30, 2017
Anticipated Primary Completion Date :
Nov 30, 2017
Anticipated Study Completion Date :
Jan 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Group 1

GA and Dexmedetomidine

Drug: Dexmedetomidine
Dexmedetomidine will be given with GS
Other Names:
  • Dexmedetomidine with scleral buckling

    		•
    group 2

    GA and peribulbar
    group3

    GA and xylocaine gel

    Outcome Measures

    Primary Outcome Measures

    1. PONV [8 hours post operative]

      incidence of post operative nausea and vomiting

    Eligibility Criteria

    Criteria

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

    • males or females

    • aged between 18-80 years

    • ASA physical status Ι&II -indicated for repair of retinal detachment with scleral buckling. -

    Exclusion Criteria:

    • Patients with cardiac, liver and/or kidney diseases

    • coagulation defects or receiving anticoagulants

    • hypersensitivity to the used drugs

    • history of motion sickness or PONV

    • diabetes mellitus

    • gastrointestinal disease

    • smokers

    • menstruating ladies

    • ASA status more than II

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Giza Egypt 1234

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hassan Mohamed Ali, lecturer of anesthesia, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03313479
    Other Study ID Numbers:
    • badawy 1
    First Posted:
    Oct 18, 2017
    Last Update Posted:
    Oct 18, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Hassan Mohamed Ali, lecturer of anesthesia, Cairo University
    Nausea, vomiting
    Additional relevant MeSH terms:
    Nausea
    Vomiting
    Postoperative Nausea and Vomiting
    Dexmedetomidine

    Study Results

    No Results Posted as of Oct 18, 2017