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

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

Sponsors

Lead sponsor: University of Catania

Source University of Catania
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.

Overall Status Unknown status
Start Date March 2015
Completion Date September 2015
Primary Completion Date August 2015
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
• 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
Secondary Outcome
Measure Time Frame
• Standardized score of nausea and/or vomiting severity if PONV occurs. 1-24 hours post-operatively
• Pain score during the immediate post-operative period. 1-24 hours post-operatively
• Number of antiemetic rescue medications given postoperatively. 1-24 hours post-operatively
• Rates of known side effects. 1-24 hours post-operatively
Enrollment 1200
Condition
Intervention

Intervention type: Drug

Intervention name: PLACEBO

Description: received normal saline, intravenously

Arm group label: PLACEBO Group

Intervention type: Drug

Intervention name: Dexamethasone

Description: 4 mg, intravenously, at the start of surgery

Arm group label: DEXAMETHASONE Group

Intervention type: Drug

Intervention name: Ondansetron

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

Arm group label: ONDANSETRON

Intervention type: Drug

Intervention name: Dexamethasone + Ondansetron

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

Arm group label: DEXAMETHASONE + ONDANSETRON

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

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Overall Contact

Last name: MICHELE REIBALDI, Professor

Phone: +39 0953781291

Email: [email protected]

Location
facility
Polytechnic University of Marche | Ancona, Marche, Italy
University of Sassari | Sassari, Sardinia, Italy
University of Catania | Catania, Sicily, 95125, Italy
Federico II University | Naples, 80131, Italy MARIO ROMANO, professor +39 081 5666780
Location Countries

Italy

Verification Date

March 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Catania

Investigator full name: REIBALDI MICHELE

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: PLACEBO Group

Arm group type: Placebo Comparator

Description: Received normal saline

Arm group label: DEXAMETHASONE Group

Arm group type: Active Comparator

Description: Received 4 mg Dexamethasone.

Arm group label: ONDANSETRON

Arm group type: Active Comparator

Description: Received 4 mg Ondansetron

Arm group label: DEXAMETHASONE + ONDANSETRON

Arm group type: Active Comparator

Description: Received 4mg Dexamethasone + 4mg Ondansetron

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov