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A comparison of Dexmedetomidine and Midazolam for intravenous sedation in outpatient lower third molar surgery (Randomized controlled trial, split-mouth technique)

A comparison of Dexmedetomidine and Midazolam for intravenous sedation in outpatient lower third molar surgery (Randomized controlled trial, split-mouth technique)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260428007
Enrollment
12
Registered
2026-04-28
Start date
2025-06-12
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

Patient who are willing to remove lower mandibular third molar at both side with moderate to high anxiety according to Corah&#039

Interventions

Dexmedetomidine 1microgram/kg dilute with NSS to total 20 ml., IV drip, slow infusion with infusion pump for 10 minutes,Midazolam 0.1 mg/kg dilute with NSS to total 20 ml., IV drip, slow infusion with
Active Comparator Drug,Active Comparator Drug

Sponsors

Department Of Oral and Maxillofacial surgery, Falculty of dentistry PSU
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1.ASA Classification I II, 2. Thai Patients who are willing to remove impacted third molar on both sides, 3. Moderate to very difficult score 5 to 10 of impacted third molar by Pedersons difficulty index, 4. Moderate to high anxiety score 9 to 14 by Corahs dental anxiety scale, 5. No sign of infection or pericoronitis

Exclusion criteria

Exclusion criteria: 1.Allergy to Dexmedetomidine, Midazolam, Benzodiazepine group, NSAIDs, including COX-2 specific inhibitors, 2.Recent use of benzodiazepine, antidepressants, 3.Clinical history or electrocardiographic evidence of heart block, ischemic heart disease, impaired liver, kidney disease, 4.Respiratory system disorders (asthma, sleep apnea syndrome), 5.Psychiatric disorders such as schizophrenia and depression, 6.Long term analgesic (over 3 months), 7.Breastfeeding or Pregnancy patient, 8.Drug or alcohol addicted, 9.Mental retard

Design outcomes

Primary

MeasureTime frame
Heart rate Baseline, injection, flap opening, remove bone, separate tooth, suture blood pressure monitor

Secondary

MeasureTime frame
score of anxiety questionnaire before and after surgery Corah's dental anxiety scale,Post-operative pain 1,3,6 hours after surgery VAS score,Time starts rescue drug The pain is unbearable, patient need to take medication subjective pain,Amnesia After surgery when fully awake Able to remember numbers (3 numbers),Nausea and vomitting After surgery Subjective perception,Patient and surgeon satisfaction After surgery (when patient fully awake) Subjective perception

Countries

Thailand

Contacts

Public ContactSurapong Vongvatcharanon

Faculty of Dentistry, Prince of Songkla University

surapong.v@psu.ac.th074429876

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026