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Dose-Finding of Vitamin B6 for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery: A Double-blind Randomized Controlled Study

Dose-Finding of Vitamin B6 for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery: A Double-blind Randomized Controlled Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101718
Enrollment
Unknown
Registered
2025-04-29
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

Postoperative Nausea and Vomiting

Interventions

0g VitB6 Group:6 ml of normal saline intravenous infusion is given prior to anesthesia induction
0.2g VitB6 Group:0.2g/4ml vitamin B6 and 2M normal saline intravenous infusion was given before anesthesia induction
0.3g VitB6 Group:0.3g/6ml vitamin B6 intravenous infusion was administered prior to anesthesia induction

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who are scheduled to undergo laparoscopic surgery under general anesthesia Age >= 18 years old ASA (American Society of Anesthesiologists) is graded as Class I~III Provide signed informed consent

Exclusion criteria

Exclusion criteria: Known allergy to vitamin B6 or use of vitamin B6 within a week prior to surgery Use of long-acting antiemetics and emetics within one week before surgery Long-term use of opioids or glucocorticoids Have other medical conditions that may cause nausea and/or vomiting (e.g., hepatitis, stomach ulcers) Postoperative treatment with an indwelling gastric tube is required Pregnant or lactating females Mental retardation, psychiatric illness, or severe neurological disorder Participation in other clinical studies within 3 months prior to enrollment in this study

Design outcomes

Primary

MeasureTime frame
Incidence of nausea and vomiting within 24 hours after surgery;Incidence of nausea;Incidence of vomiting;

Secondary

MeasureTime frame
Incidence of nausea and vomiting in the early postoperative period;Incidence of nausea and vomiting in late postoperative stages;The severity of the patient's nausea at 24 hours postoperatively (0 none; 1 mild; 2 medium; 3 violent);Number of vomits (1, 2, = 3);Time to first onset of nausea or vomiting (hours);Treatment of anti-nausea medications;Maximum pain score at rest/exercise within 24 hours postoperatively;Duration of stay in the PACU;Length of hospital stay;Hospitalization costs;The severity of the patient's vomiting at 24 hours postoperatively (0 none; 1 mild; 2 medium; 3 violent);

Countries

China

Contacts

Public ContactLe Yuan

Department of Anesthesiology, Third Xiangya Hospital, Central South University

leyuanxy@csu.edu.cn+86 137 8710 7617

Outcome results

None listed

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