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NCT05371600
Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption
Phase 4 trial testing Midazolam in Midazolam in 80 participants. Completed in 30 April 2024.
30 April 2024
Quick facts
| Lead sponsor | Cukurova University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 2 December 2022 |
| Primary completion | 30 April 2024 |
| Estimated completion | 30 April 2024 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Midazolam (midazolam) — full drug profile →
- Saline
Conditions studied
- Midazolam — all drugs for Midazolam →
- Sevoflurane — all drugs for Sevoflurane →
Sponsor
Cukurova University
Who can join
Adults 18 to 60, any sex, with Midazolam or Sevoflurane. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This prospective, randomized, double-blind, placebo-controlled study is performed after obtaining written informed consent of patients who are scheduled for elective general surgery. After the admission to the preoperative unit 30 minutes before the surgery, The preoperative anxiety of patients is evaluated by The State-Trait Anxiety Inventory (STAI). Patients are randomly assigned to one of two groups in a 1:1 ratio by a computer-generated list. Patients receive midazolam IV at 0.04 mg/kg (group M) and an equal volume of saline IV (group C, control group). Anesthesia is induced with 2mg/kg of IV propofol. At a dose of 0.6 mg/kg, IV rocuronium bromide is given for neuromuscular blockade. Anesthesia is maintained at 2% sevoflurane. At the end of the surgery, anesthesia is terminated and the awake patients are extubated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05371600
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05371600 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cukurova University
- Last refreshed: 1 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05371600.
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