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

Comparative Study of the Effect of Three Different Analgesic Techniques on the Incidence of Postoperative Nausea and Vomiting After Scleral Buckling Under General Anesthesia

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

Study Overview

• Status: Unknown
• Conditions: Post Operative Nausea and Vomiting
• Intervention / Treatment: 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
• Enrollment (Anticipated): 75

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 1234
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients undergo repair of retinal detachment with scleral buckling

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONV	incidence of post operative nausea and vomiting	8 hours post operative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2017
• Primary Completion (Anticipated): November 30, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: October 7, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Nausea, vomiting
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: badawy 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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