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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03313479
Other study ID # badawy 1
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 7, 2017
Last updated October 13, 2017
Start date October 30, 2017
Est. completion date January 1, 2018

Study information

Verified date October 2017
Source Cairo University
Contact Hassan Ali, lecturer
Phone 1001733687
Email hassan364@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date January 1, 2018
Est. primary completion date November 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- males or females

- aged between 18-80 years

- ASA physical status ?&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 Design


Related Conditions & MeSH terms

  • Nausea
  • Post Operative Nausea and Vomiting
  • Postoperative Nausea and Vomiting
  • Vomiting

Intervention

Drug:
Dexmedetomidine
Dexmedetomidine will be given with GS

Locations

Country Name City State
Egypt Cairo University Cairo Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary PONV incidence of post operative nausea and vomiting 8 hours post operative
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