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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220510001
Enrollment
300
Registered
2022-05-10
Start date
2022-05-12
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

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

Interventions

Dexamethasone IV was given as a &#039
syringe no. 1 &#039
after induction of anesthesia in dose of 4 mg . Midazolam 0.04 mg/kg (max 2 mg ) dilute up to 2 mL (1mg/mL) IV was given as a &#039
syringe no. 2 &#039
just 30 min before the operation was done. ondansetron is the open-label drug which given in the same dose in both arms ,Dexamethasone IV was given as a &#039
after induction of anesthesia in dose of 8 mg . Normal saline 2 mL IV was given as a &#039
just 30 min before the operation was done. ondansetron is the open-label drug which given in the same dose in both arms
Active Comparator Drug,Active Comparator Drug
dexamethasone+ ondansetron+midazolam (DOM),dexamethasone+ ondansetron (DO)

Sponsors

Faculty of Medicine, Chulalongkorn university
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
post operative nausea and vomiting 24 hours incidence of post operative nausea and vomiting

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactKullaporn Mingvoramethakul

Faculty of medicine , Chulalongkorn university

mintkllprn@gmail.com0918845151

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026