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The Effect of Dexmedetomidine Infusion Versus Placebo on Reducing Postoperative Opioid Consumption In Patients Undergoing Elective Spine Surgery: A Randomized Controlled Trial.

The Effect of Dexmedetomidine Infusion Versus Placebo on Reducing Postoperative Opioid Consumption In Patients Undergoing Elective Spine Surgery: A Randomized Controlled Trial.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250903001
Enrollment
98
Registered
2025-09-03
Start date
2025-10-29
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 aged 18 years old or older undergoing elective spine surgery involving two or more levels dexmedetomidine, non-opioid analgesics, morphine consumption, postoperative pain, adverse drug reactions, intraoperative blood loss, spine surgery, controlled hypotension

Interventions

Dexmedetomidine (4 mcg/ml) intravenous infusion 0.5 mcg/kg/hour of ideal body weight,0.9%NaCl intravenous infusion
Active Comparator Drug,Placebo Comparator No treatment

Sponsors

Faculty of medicine, Chulalongkorn university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years or older 2.Patients undergoing elective spinal surgery involving two or more levels

Exclusion criteria

Exclusion criteria: 1.Patients undergoing emergency spinal surgery 2.Patients who decline to participate in the study 3.Patients with a history of allergy to any drugs used in this study 4.Patients with severe cardiac arrhythmias, including Second-degree AV block, Mobitz type II, Third-degree AV block 5.Pregnant or breastfeeding women 6.Patients unable to use intravenous patient-controlled analgesia 7.Patients with a history of substance abuse or preoperative opioid use 8.Patients with a glomerular filtration rate < 60 mL/min/1.73 square meter

Design outcomes

Primary

MeasureTime frame
postoperative opioid consumption 24 hrs after surgery Morphine Milligram Equivalents, MME

Secondary

MeasureTime frame
Pain score immediately post operation, 1hrs, 3 hrs, 6 hrs, 12 hrs, 24 hrs and 48 hrs after surgery The numeric rating scale (NRS) ,postoperative opioid consumption 1 hrs,3 hrs, 6 hrs, 12 hrs and 48 hrs after surgery Morphine Milligram Equivalents, MME,Time to first opioid administration Time to first opioid administration from arrival in the recovery room minutes ,Time to successful extubation Time to successful extubation, measured from discontinuation of inhalation anesthetics minutes,Incidence and severity of postoperative nausea and vomiting (PONV) immediately post operation, 1hrs, 3 hrs, 6 hrs, 12 hrs, 24 hrs and 48 hrs after surgery PONV impact scale,Patient satisfaction level 24 hrs and 48 hrs after surgery five-point Likert scale,Quality of recovery 48 hrs after surgery 15-item quality of recovery (QoR-15) scale,Incidence of adverse events Intraoperative period to 48 hrs after surgery Times,Intraoperative blood loss intraoperative period milliliter

Countries

Thailand

Contacts

Public ContactPunyaporn Imchai

Faculty of Medicine, Chulalongkorn University

punyaporn.im@gmail.com022564000

Outcome results

None listed

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