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

NCT02386059 | Unknown Phase 4

• 1 other identifier: UCatania
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 4

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

ondansetron; dexamethasone; vitrectomy; local anesthesia

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (4)

• • 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

Study Arms (4)

PLACEBO Group

PLACEBO COMPARATOR

Received normal saline

Drug: PLACEBO

DEXAMETHASONE Group

ACTIVE COMPARATOR

Received 4 mg Dexamethasone.

Drug: Dexamethasone

ONDANSETRON

ACTIVE COMPARATOR

Received 4 mg Ondansetron

Drug: Ondansetron

DEXAMETHASONE + ONDANSETRON

ACTIVE COMPARATOR

Received 4mg Dexamethasone + 4mg Ondansetron

Drug: Dexamethasone + Ondansetron

Interventions

PLACEBO DRUG

received normal saline, intravenously

PLACEBO Group

Dexamethasone DRUG

4 mg, intravenously, at the start of surgery

DEXAMETHASONE Group

Ondansetron DRUG

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

ONDANSETRON

Dexamethasone + Ondansetron DRUG

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

DEXAMETHASONE + ONDANSETRON

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older with an American Society of Anesthesiologists (ASA) physical status of I to II
• Scheduled for vitrectomy under local anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Catania: lead

Study Sites (4)

Federico II University

Naples, Italy, 80131, Italy

Location

University of Sassari

Sassari, Sardinia, Italy

Location

University of Catania

Catania, Sicily, 95125, Italy

Location

Polytechnic University of Marche

Ancona, The Marches, Italy

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

MICHELE REIBALDI, Professor

CONTACT

+39 0953781291; mreibaldi@libero.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 11, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

IT (4)