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

University of Catania

Status and phase: Unknown; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: PLACEBO; Drug: Dexamethasone; Drug: Dexamethasone + Ondansetron; Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02386059

UCatania

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,200 participants in 4 patient groups, including a placebo group

PLACEBO Group

Placebo Comparator group

Description:

Received normal saline

Treatment:

Drug: PLACEBO

DEXAMETHASONE Group

Active Comparator group

Description:

Received 4 mg Dexamethasone.

Treatment:

Drug: Dexamethasone

ONDANSETRON

Active Comparator group

Description:

Received 4 mg Ondansetron

Treatment:

Drug: Ondansetron

DEXAMETHASONE + ONDANSETRON

Active Comparator group

Description:

Received 4mg Dexamethasone + 4mg Ondansetron

Treatment:

Drug: Dexamethasone + Ondansetron