Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia

Postoperative Nausea and Vomiting Clinical Trial

Official title:

A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02386059
• Other study ID #: UCatania
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 5, 2015
• Last updated: March 10, 2015
• Start date: March 2015
• Est. completion date: September 2015

Study information

• Verified date: March 2015
• Source: University of Catania
• Contact: MICHELE REIBALDI, Professor
• Phone: +39 0953781291
• Email: mreibaldi[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence may be the long duration of surgery and anesthesia and the high degree of manipulation of the eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset of several complications, such as suprachoroidal hemorrhage, with disastrous visual consequences.

To date there is no evidence as to the possible protective effect of anti-emetic therapy with regard to interventions of vitrectomy performed under local anesthesia.

In this prospective, randomized, multicenter, double blind study, we evaluated the efficacy of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and vomiting in patients undergoing vitrectomy under local anesthesia.

Description:

Patients were randomly stratified to receive 1 of 4 prophylactic antiemetic treatments (3 pharmaceutical treatment and 1 placebo) in a double-blind manner at the start of the surgery and 15 minutes before the end of surgery.

The syringes were prepared by a third, neutral person not involved in the perioperative care of the patient, immediately before the start of anesthesia.

All vitrectomy surgeries were performed, in each unit,under local anesthesia by a retrobulbar block.

Each patients was observed and treated during a period of 24 hours after the surgery. For patients who have nausea and vomiting despite the antiemetic prophylaxis, will be given a rescue dose of 4 mg ondansetron IV.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 18 or older with an American Society of Anesthesiologists (ASA) physical status of I to II

• Scheduled for vitrectomy under local anesthesia

Exclusion Criteria:

• Hypersensitivity to study drug or rescue medication

• Preoperative score for nausea greater than 4 out of 10 points

• Subjects who suffer from chronic nausea and/or vomiting

• Severe hepatic insufficiency (Child-Pugh score > 9)

• Other antiemetic within 12 hours prior to surgery

• Patients unable to undergo a local anesthetic

• Subjects with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease

• Psychotic illness or depression

• Addiction to illicit substances or alcohol

• Non-psychotic emotional disorders

• Pregnant or lactating

• Subjects who, in the opinion of the investigator, would experience an unacceptable risk from administration of study drug

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• PLACEBO
received normal saline, intravenously
• Dexamethasone
4 mg, intravenously, at the start of surgery
• Ondansetron
4 mg, intravenously, 15 minutes before the end of surgery.
• Dexamethasone + Ondansetron
4 mg dexamethasone, intravenously at the start of surgery and 4 mg ondansetron intravenously 15 minutes before the end of surgery.

Locations

Country	Name	City	State
Italy	Polytechnic University of Marche	Ancona	Marche
Italy	University of Catania	Catania	Sicily
Italy	Federico II University	Naples
Italy	University of Sassari	Sassari	Sardinia

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Proportion of patients with Complete Response (no nausea, no vomiting, no retching, and no use of rescue medication) during the first 24 hours after surgery		1-24 hours post-operatively	No
Secondary	• Standardized score of nausea and/or vomiting severity if PONV occurs.		1-24 hours post-operatively	No
Secondary	• Pain score during the immediate post-operative period.		1-24 hours post-operatively	No
Secondary	• Number of antiemetic rescue medications given postoperatively.		1-24 hours post-operatively	No
Secondary	• Rates of known side effects.		1-24 hours post-operatively	No