Drug Use
Conditions
Brief summary
The purpose is to compare the efficacy of combined regional nasal block and general anesthesia versus general anesthesia with dexmedetomidine during endoscopic sinus surgery in optimizing intraoperative surgical field.
Detailed description
This study will be done to compare between two different techniques including regional nasal block and dexmedetomidine in optimizing intraoperative surgical field according to average category scale
Interventions
using nasal block including sphenopalatine ganglion block with general anesthesia to optimize surgical field
DRUGDexmedetomidine
using dexmedetomidine with induction of general anesthesia to optimize surgical field
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients of ASA I or ASA II physical status. * Patients with age 18-65 years.
Exclusion criteria
* Patients with physical status ASA III, IV. * Known allergic reactions to local anesthetics. * Patients with history for cerebrovascular or coronary insufficiency. * Patients with infection at the block site. * Patients with coagulopathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimizing intraoperative surgical field | Up to 6 months | Comparison between efficacy of the two techniques in optimizing intraoperative surgical field which will be measured using the average category scale(where grade 0 is defined as no bleeding and grade 5 is defined as severe bleeding, constant suctioning required). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss in millilitres | Up to 8 months | Blood loss will be measured in millilitres as that collected in the suction apparatus and by weight of the nasal swabs. |
| endtidal sevoflurane concentration in MAC% | Up to 8 months | Endtidal sevoflurane concentration will be used as an indicator of inhaled anaesthetic dose. Mean end-tidal sevoflurane concentration will be calculated for each patient as the average of all concentrations recorded will be measured in MAC% |
| phentolamine requirements in milligrams | Up to 8 months | The total dose of additional hypotensive agent (phentolamine) requirements will be measured in milligrams |
| Heart rate in beat per minute | Up to 8 months | The heart rate will be measured in (beat/minute) at the commencement of surgery and at each assessment of the surgical field. The average mean values during the surgical procedures will be calculated in each group. |
| Pain assessment with visual analogue scale(VAS) | Up to 8 months | Pain intensity will be measured with a 10-cm visual analogue scale (where 0 is defined as no pain at all and 10 as the worst possible pain) at 2, 6 and 12 hours postoperatively. |
| Mean blood pressure in mmHg | Up to 8 months | The mean blood pressure will be measured in mmHg at the commencement of surgery and at each assessment of the surgical field. The average mean values during the surgical procedures will be calculated in each group. |
| Duration of surgery in minutes | Up to 8 months | Duration of surgery will be measured in minutes |
| Duration of anesthesia in minutes | Up to 8 months | Duration of anesthesia will be measured in minutes |
Countries
Egypt
Contacts
Primary ContactMoustafa At Moustafa Hamouda, Ass lecturer
Backup ContactRehab Ab Abdelrazik Elsayed, Lecturer
Outcome results
None listed