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

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ClinicalTrials.gov Identifier: NCT03313479
Recruitment Status : Not yet recruiting
First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Hassan Mohamed Ali, Cairo University

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
Post Operative Nausea and Vomiting Drug: Dexmedetomidine

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 Type : Observational
Estimated 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
Estimated Study Start Date : October 30, 2017
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
GA and Dexmedetomidine
Drug: Dexmedetomidine
Dexmedetomidine will be given with GS
Other Name: Dexmedetomidine with scleral buckling

group 2
GA and peribulbar
group3
GA and xylocaine gel



Primary Outcome Measures :
  1. PONV [ Time Frame: 8 hours post operative ]
    incidence of post operative nausea and vomiting



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients undergo repair of retinal detachment with scleral buckling
Criteria

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

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): NCT03313479


Contacts
Contact: Hassan Ali, lecturer 1001733687 hassan364@hotmail.com
Contact: Ahmed Badwy, lecturer 1001733687 hassan364@hotmail.com

Locations
Egypt
Cairo University Recruiting
Cairo, Giza, Egypt, 1234
Contact: HASSAN M ALI, LECTURER    +201001733687    hassan364@hotmail.com   
Sponsors and Collaborators
Cairo University

Responsible Party: Hassan Mohamed Ali, lecturer of anesthesia, Cairo University
ClinicalTrials.gov Identifier: NCT03313479     History of Changes
Other Study ID Numbers: badawy 1
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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, Cairo University:
Nausea, vomiting

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexmedetomidine
Analgesics
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action