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

NCT ID: NCT02386059

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-09-30

Brief 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.

Detailed 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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

PLACEBO Group

Received normal saline

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

received normal saline, intravenously

DEXAMETHASONE Group

Received 4 mg Dexamethasone.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

4 mg, intravenously, at the start of surgery

ONDANSETRON

Received 4 mg Ondansetron

Group Type: ACTIVE_COMPARATOR

Ondansetron

Intervention Type: DRUG

4 mg, intravenously, 15 minutes before the end of surgery.

DEXAMETHASONE + ONDANSETRON

Received 4mg Dexamethasone + 4mg Ondansetron

Group Type: ACTIVE_COMPARATOR

Dexamethasone + Ondansetron

Intervention Type: DRUG

4 mg dexamethasone, intravenously at the start of surgery and 4 mg ondansetron intravenously 15 minutes before the end of surgery.

Interventions

PLACEBO

received normal saline, intravenously

Intervention Type: DRUG

Dexamethasone

4 mg, intravenously, at the start of surgery

Intervention Type: DRUG

Ondansetron

4 mg, intravenously, 15 minutes before the end of surgery.

Intervention Type: DRUG

Dexamethasone + Ondansetron

4 mg dexamethasone, intravenously at the start of surgery and 4 mg ondansetron intravenously 15 minutes before the end of surgery.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Catania

OTHER

Sponsor Role: lead

Responsible Party

REIBALDI MICHELE

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federico II University

Naples, Italy, Italy

University of Sassari

Sassari, Sardinia, Italy

University of Catania

Catania, Sicily, Italy

Polytechnic University of Marche

Ancona, The Marches, Italy

Countries

Italy

Central Contacts

MICHELE REIBALDI, Professor

Role: CONTACT

mreibaldi@libero.it

+39 0953781291

Facility Contacts

MARIO ROMANO, professor

Role: primary

+39 081 5666780

Other Identifiers

UCatania

Identifier Type: -

Identifier Source: org_study_id