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Enrolling by invitation NCT07380139

Dexamethasone vs Dexmedetomidine in Sphenopalatine Ganglion Block for Rhinoplasty Pain

Phase I Interventional Post Operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexamedomedine, Dexamethasone, Bubpivacaine.
Who it may be relevant to
Registry conditions: Post Operative Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Dexamethasone Versus Dexmedetomidine as Adjuvant to Bupivacaine in Sphenopalatine Ganglion Block as Post-operative Analgesia in Rhinoplasty Surgeries

Overview

This study will test the effect of adding dexamethasone versus dexmedetomidine as adjuvants to bupivacaine in sphenopalatine ganglion block used for pain after rhinoplasty

Detailed description

Preoperative settings:

Preoperative evaluation of full medical history will be taken, examination will be done, and routine preoperative investigations will be done to all patients including complete blood picture and coagulation profile.

The patient will be fasting for at least 8 hours preoperatively

Intraoperative settings:

General anesthesia technique:

Upon arrival to OR, Standard monitoring will be applied: ECG, non-invasive blood pressure and pulse oximeter, Intravenous access (20G) will be inserted, and all patients will receive midazolam 0.05mg/kg IV for anxiety, ranitidine 50 mg IV and ondansetron 0.15mg/kg IV 15 min before induction.

Induction of anesthesia in all groups will be done by intravenous propofol 2-2.5 mg/kg IV, fentanyl 1 µg/kg IV and atracurium 0.5 mg/kg IV, then endotracheal tube of suitable size will be applied and capnogram will be connected. Maintenance will be achieved by isoflurane inhalation started with 1.2 % and top-up doses of atracurium (0.01 mg/kg IV). Volume controlled positive pressure ventilation was adjusted at tidal volume and respiratory rate to keep ETCO2 at 35-40 mmHg with continuous monitoring. During surgery, the patients received intravenous infusion of ringer solution according to fluid requirement regimen. Fluid administration will be guided by hemodynamics monitoring and clinical parameters

Interventions

  • Drug Dexamedomedine
    will receive bupivacaine 0.25% (3ml) + dexmedetomidine (1 mic/kg), total volume 5ml by adding normal saline.
  • Drug Dexamethasone
    will receive bupivacaine 0.25% (3ml) + dexamethasone (4mg), total volume 5ml by adding normal saline
  • Drug Bubpivacaine
    will receive bupivacaine 0.25% (3ml) + normal saline, total volume (5 ml).

Primary outcome measures

  • The time to the first request of analgesia [Time frame: 9 months]

Eligibility criteria

Inclusion criteria

  • Age 18-65 years.
  • Sex: of either sex.
  • American Society of Anaesthesiologists (ASA) Physical Status Class I and II.
  • BMI < 35
  • Scheduled for rhinoplasty surgeries under general anaesthesia.

Exclusion criteria

  • Declining to give written informed consent.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
  • Psychiatric disorder.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT07380139 · FMASU MD255/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗