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Effect of Intranasal Dexmedetomidine on Postoperative Strabismus Surgery

Effect of Intranasal Dexmedetomidine Compared with Placebo on Postoperative Pain in Patients Undergoing Strabismus Surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251016067646N1
Enrollment
100
Registered
2025-10-20
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Condition 1: Strabismus. Condition 2: Strabismus. Other strabismus Paralytic strabismus

Interventions

Intervention 1: The intervention group: recipients of intranasal dexmedetomidine at a dose of 1 microgram per kilogram, sprayed into both nostrils using a needleless syringe, approximately 45 minutes

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age above 18 years old Candidates for strabismus surgery under general anesthesia ASA physical score class I or II Standard preoperative fasting: at least 4 hours for clear fluids and 6 hours for solid food Written informed consent obtained from the participant (or their legal guardian, if applicable)

Exclusion criteria

Exclusion criteria: Pregnancy or lactation Use of antiemetic drugs (such as metoclopramide, ondansetron, or granisetron) Use of steroidal, opioid, or other emetogenic agents Presence of chronic diseases such as uncontrolled cardiac, renal, or diabetic disorders History of active vomiting within the past 24 hours Known hypersensitivity to the study drugs Psychiatric disorders or history of substance abuse

Design outcomes

Primary

MeasureTime frame
Postoperative pain score. Timepoint: 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after surgery. Method of measurement: Visual Analogue Scale score.;Patient satisfaction. Timepoint: 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after surgery. Method of measurement: Visual Analogue Scale score.;Need for rescue analgesia. Timepoint: 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after surgery. Method of measurement: Visual Analogue Scale score more than 4.;Postoperative Nausea and Vomiting. Timepoint: 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after surgery. Method of measurement: Yes or no.;Emergence Agitation. Timepoint: 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after surgery. Method of measurement: Yes or no.;Systolic, diastolic and mean arterial blood pressure. Timepoint: During surgery, 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after surgery. Method of measurement: Automatic blood pressure monitor.;O2 saturation. Timepoint: During surgery, 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after surgery. Method of measurement: Pulse Oximeter.;Pulse rate. Timepoint: During surgery, 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after surgery. Method of measurement: Pulse oximeter.

Secondary

MeasureTime frame
Post-anesthesia care unit stay duration. Timepoint: Every 1 hour. Method of measurement: Based on entrance and discharge time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Azadian

Esfahan University of Medical Sciences

ali_azadian@icloud.com+98 913 445 1465

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026