Vitamin C as PONV prophylaxis

PONV – Histamin - Vitamin C A prospecitve, Placebo-controlled dobbleblind study - PONVit C

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001239-11-AT

Enrollment

298

Registered

2016-09-20

Start date

2016-10-17

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PONV

Interventions

Trade Name: Cevitol Product Name: Cevitol Product Code: A11GA01 Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: ASCORBIC ACID CAS Number: 50-81-7 Current Spon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who undergo a primary elecitve knee or hip total endoprothesis surgery (1500 patients per year) in the Orthopaedics Hospital Speising between age 18-80 years ASA Group I or II presenting at least 2 out of 4 of following PONV risk factors: female, non-Smoking, PONV history, kinetosis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 218

Exclusion criteria

Exclusion criteria: children Age >80 years Smoking men without PONV history and motion sickness ASA Group III or IV acute and other surgeries pregnancy

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): The main dependent variables are the intraoperative Histamin Levels in the Vitamin C vs the antihistamin Group (branch B vs Branch C).;Timepoint(s) of evaluation of this end point: time Point 2 (immediately after Infusion) time Point 3 (after induction of anaesthesia)	—

Primary

Measure	Time frame
Main Objective: The occurance of postoperative Nausea and vomiting (PONV) does not differ significantly from Placebo and Vitamin C Group (branches A and B).;Secondary Objective: The intraoperative trend of Histamin levels of the Vitamin C and the Antihistamin group (branches B and C) does not differ from each other.;Primary end point(s): The main dependent variable is the occurance of PONV up to 48 hours after surgery (yes/no criteria) in the Placebo vs. Vitamin C Group.;Timepoint(s) of evaluation of this end point: 48 hours after surgery	—

Measure

Time frame

Main Objective: The occurance of postoperative Nausea and vomiting (PONV) does not differ significantly from Placebo and Vitamin C Group (branches A and B).;Secondary Objective: The intraoperative trend of Histamin levels of the Vitamin C and the Antihistamin group (branches B and C) does not differ from each other.;Primary end point(s): The main dependent variable is the occurance of PONV up to 48 hours after surgery (yes/no criteria) in the Placebo vs. Vitamin C Group.;Timepoint(s) of evaluation of this end point: 48 hours after surgery

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Countries

Austria

Contacts

Public ContactDepartment of anesthesia

Orthopädisches Spital Speising

judit.lehninger@oss.at+431801821865

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026