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Investigation of the Effect of Dexamethasone on Reducing Swelling and Bruising after Rhinoplasty

Comparison of the Effect of Dexamethasone on Reducing Edema and Ecchymosis after Rhinoplasty

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260420069115N1
Enrollment
60
Registered
2026-04-26
Start date
2025-07-23
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Post-rhinoplasty edema and ecchymosis.

Interventions

Intervention 1: Intervention group: Intervention group 1: Subcutaneous dexamethasone 0.15 mg/kgFull details:Drug: DexamethasoneDose: 0.15 mg/kg (patient weight)Route: Subcutaneous injectionTiming: Imm

Sponsors

Zahedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 40 years Candidates for rhinoplasty with lateral osteotomy Suitable physical status for general anesthesia Written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: History of diabetes mellitus History of peptic ulcer Psychiatric disorders Active tuberculosis or active infection Hypersensitivity to steroids History of corticosteroid use Coagulation disorders

Design outcomes

Primary

MeasureTime frame
Severity of edema (score 0 to 4)Description:0 = no edema1 = mild2 = moderate3 = severe4 = very severeMeasured at 1, 24, and 48 hours post-rhinoplasty by blinded assessor. Timepoint: Measurement at 1, 24, and 48 hours post-rhinoplastyFull description:Severity of edema measured by blinded assessor at the following time points:1 hour after surgery completion24 hours after surgery48 hours after surgery. Method of measurement: Clinical assessment by blinded assessor Full description: Tool: Direct observation + Kara/Gokalan standard scale (0-4) Method: Independent surgeon (blinded to intervention) scores periorbital edema severity Standard: Gold standard method in rhinoplasty studies (non-digital photography).

Secondary

MeasureTime frame
Severity of ecchymosis (score 0 to 4)Description:0 = no ecchymosis1 = mild2 = moderate3 = severe4 = very severe. Timepoint: Measurement at 1, 24, and 48 hours post-rhinoplastyFull description:Severity of ecchymosis measured by blinded assessor at:1 hour after surgery completion24 hours after surgery48 hours after surgery. Method of measurement: Clinical assessment by blinded assessorFull description:Tool: Direct observation + Kara and Gokalan standard scale (0-4)Method: Independent surgeon (blinded to intervention) scores periorbital ecchymosis severityStandard: Identical to edema assessment (inter-rater reliability ICC > 0.9).;Duration of complete resolution of edema and ecchymosisDescription:Time from end of rhinoplasty surgery until complete disappearance (score=0) of both periorbital edema and ecchymosisMeasured daily by blinded assessor until score=0 achieved for both outcomes. Timepoint: Daily measurement from end of surgery until complete resolution Full description:Start: Immediately after rhinoplasty completion Intervals: Every 24 hours (daily)End: When both edema and ecchymosis reach score=0. Method of measurement: Daily clinical assessment by blinded assessor Full description: Tool: Kara and Gokalan scale (0-4) for both edema and ecchymosis Stop criterion: Both conditions reach score=0Method: Direct observation + recording exact time of complete resolution Standard: Protocol used in corticosteroid rhinoplasty studies.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholamali Dashti Khoydaki

Zahedan University of Medical Sciences

g.dashti@zums.ac.ir+98 54 3342 9501

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026