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

Primary Purpose

Postoperative Nausea and Vomiting

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

PLACEBO

Dexamethasone

Ondansetron

Dexamethasone + Ondansetron

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring ondansetron, dexamethasone, vitrectomy, local anesthesia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Polytechnic University of Marche
University of Sassari
University of Catania
Federico II University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

PLACEBO Group

DEXAMETHASONE Group

ONDANSETRON

DEXAMETHASONE + ONDANSETRON

Arm Description

Received normal saline

Received 4 mg Dexamethasone.

Received 4 mg Ondansetron

Received 4mg Dexamethasone + 4mg Ondansetron

Outcomes

Primary Outcome Measures

• 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

Secondary Outcome Measures

• Standardized score of nausea and/or vomiting severity if PONV occurs.

• Pain score during the immediate post-operative period.

• Number of antiemetic rescue medications given postoperatively.

• Rates of known side effects.

Full Information

NCT ID

NCT02386059

First Posted

March 5, 2015

Last Updated

March 10, 2015

Sponsor

University of Catania

1. Study Identification

Unique Protocol Identification Number

NCT02386059

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

August 2015 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Catania

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

Keywords

ondansetron, dexamethasone, vitrectomy, local anesthesia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PLACEBO Group

Arm Type

Placebo Comparator

Arm Description

Received normal saline

Arm Title

DEXAMETHASONE Group

Arm Type

Active Comparator

Arm Description

Received 4 mg Dexamethasone.

Arm Title

ONDANSETRON

Arm Type

Active Comparator

Arm Description

Received 4 mg Ondansetron

Arm Title

DEXAMETHASONE + ONDANSETRON

Arm Type

Active Comparator

Arm Description

Received 4mg Dexamethasone + 4mg Ondansetron

Intervention Type

Drug

Intervention Name(s)

PLACEBO

Intervention Description

received normal saline, intravenously

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

4 mg, intravenously, at the start of surgery

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone + Ondansetron

Intervention Description

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

Primary Outcome Measure Information:

Title

• 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

Time Frame

1-24 hours post-operatively

Secondary Outcome Measure Information:

Title

• Standardized score of nausea and/or vomiting severity if PONV occurs.

Time Frame

1-24 hours post-operatively

Title

• Pain score during the immediate post-operative period.

Time Frame

1-24 hours post-operatively

Title

• Number of antiemetic rescue medications given postoperatively.

Time Frame

1-24 hours post-operatively

Title

• Rates of known side effects.

Time Frame

1-24 hours post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

MICHELE REIBALDI, Professor

Phone

+39 0953781291

mreibaldi@libero.it

Facility Information:

Facility Name

Polytechnic University of Marche

City

Ancona

State/Province

Marche

Country

Italy

Facility Name

University of Sassari

City

Sassari

State/Province

Sardinia

Country

Italy

Facility Name

University of Catania

City

Catania

State/Province

Sicily

ZIP/Postal Code

95125

Country

Italy

Facility Name

Federico II University

City

Naples

ZIP/Postal Code

80131

Country

Italy

Facility Contact:

First Name & Middle Initial & Last Name & Degree

MARIO ROMANO, professor

Phone

+39 081 5666780

12. IPD Sharing Statement

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

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