Dexamethasone Versus Dexmedetomidine as Adjuvant to Bupivacaine in Sphenopalatine Ganglion Block as Post-operative Analgesia in Rhinoplasty Surgeries
Overview
- Phase
- Phase 1
- Status
- Enrolling By Invitation
- Sponsor
- Ain Shams University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- The time to the first request of analgesia
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18-65 years.
- •Sex: of either sex.
- •American Society of Anaesthesiologists (ASA) Physical Status Class I and II.
- •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.
Arms & Interventions
Group BD
Group BD: will receive bupivacaine 0.25% (3ml) + dexamethasone (4mg), total volume 5ml by adding normal saline
Intervention: Dexamethasone (Drug)
Group B
Group B (control group): will receive bupivacaine 0.25% (3ml) + normal saline, total volume (5 ml).
Intervention: Bubpivacaine (Drug)
Group BDX
Group BDX: will receive bupivacaine 0.25% (3ml) + dexmedetomidine (1 mic/kg), total volume 5ml by adding normal saline.
Intervention: Dexamedomedine (Drug)
Outcomes
Primary Outcomes
The time to the first request of analgesia
Time Frame: 9 months
The time interval between the onset of the local infiltration done at the end of the operation and the first request to postoperative analgesia
Secondary Outcomes
No secondary outcomes reported