The effects of adding intravenous midazolam into a dual postoperative nausea and vomiting regimen in patients undergoing breast surgery: a pragmatic randomized controlled trial

Phase 4

Completed

• Conditions: female patients undergoing breast surgery; Breast surgery; Post operative nausea and vomiting; Postoperative pain score; Blood glucose; Sedation score

• Registration Number: TCTR20220510001
• Lead Sponsor: Faculty of Medicine, Chulalongkorn university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-10
• Study Completion: 2023-07-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 298

Inclusion Criteria

1. Female age 18-65 years old , 2.ASA physical status I-III, 3. BMI 18 - 40 kg/m2

Exclusion Criteria

1. Patient's refusal ,2. Allergic or contraindicate to drug in this trial ,3. Chronic opioid use ( >3 mo) , 4.Chronic benzodiazepine use , 5.Antipsychotic use, 6.previous anticancer chemotherapy within 1 month, 6. Pregnancy ,7.OSA patient ,8. Poor controlled DM (HbA1C>9) , 9. Hx receiving antiemetic within 24 hr

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
post operative nausea and vomiting 24 hours incidence of post operative nausea and vomiting

Secondary Outcome Measures

Name	Time	Method
Severity of postoperative nausea-vomiting at 0 hr ,within 0-2, 2-6, 6-12 , 12-24 hours PONV score,Requirement of rescue antiemetic within 24 hours patient requirement for additional antiemetic drug,Satisfaction for relieving postoperative nausea/vomiting 24 hours postoperative Likert scale 1-5,Pain score at 0 hour , within 0-2 , 2-6, 6-12, 12-24 hours VAS for pain score,Duration of PACU stay Time from admit to discharge from PACU Time from admit to discharge from PACU,Sore throat at 0 hr ,within 0-2, 2-6, 6-12 , 12-24 hours patient were asked if they had sore throat,Sedation score 0 , 30 min , 60 min in PACU observer's assessment of alertness/sedation,Time to eye opening time from discontinuing inhalation to eye opening time from discontinuing inhalation to eye opening,Time to extubation time from discontinuing inhalation to extubation time from discontinuing inhalation to extubation,Blood glucose level preop and at PACU POCT glucose