General Anesthesia, Quality of Surgical Field, Sphenopalatine Ganglion Block, Trans-Sphenoidal Endoscopic Hypophysectomy
Conditions
Brief summary
This study aims to evaluate the efficacy of ultrasound guided sphenopalatine ganglion block (SPGB) through the suprazygomatic approach in optimizing the quality of surgical field as well as its effect on postoperative pain relief in patients undergoing transsphenoidal pituitary surgeries under general anesthesia.
Detailed description
The main surgical treatment for pituitary adenomas is endoscopic trans-sphenoidal hypophysectomy. Among the many regional blocks used is the sphenopalatine ganglion block (SPGB). It is one of the parasympathetic ganglia in the head, located in the pterygopalatine fossa, posterior to the middle nasal turbinate, 1-5 mm deep to the mucosa, anterior to the pterygoid canal and lateral to the sphenopalatine foramen. This superficial location makes it easy to block the ganglion transnasally by topical anesthesia or by injection through many approaches including transnasal, intraoral, infrazygomatic and suprazygomatic approaches.
Interventions
DRUGSphenopalatine ganglion block using bupivacaine + dexamethasone
Patients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone.
OTHERGeneral anesthesia
Patients will receive general anesthesia alone.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Months to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age between 21 and 60 years. * American Society of Anesthesiologists (ASA) Physical Status I or II. * Undergoing elective endoscopic trans-nasal resection of pituitary adenoma.
Exclusion criteria
* Patient's refusal * ASA Physical Status III or IV patients * Patients receiving drugs influencing blood coagulation * Allergy to any of the drugs utilized in this study * History of chronic pain therapy * Inadvertent intra-operative vascular injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of surgical field visibility | Intraoperatively | Quality of surgical field visibility will be measured at the beginning of surgery and at 30 mins interval through a pre-defined average category scale (ACS) (from 0 to 5). The ideal category scale values for surgical conditions were pre-determined to be ≤3. 0=No bleeding 1. Slight bleeding - no suctioning of blood required 2. Slight bleeding - occasional suctioning required. Surgical field not threatened 3. Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed 4. Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed 5. Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative fentanyl consumption | Intraoperatively | The hemodynamic objective of the anesthetic plan is to maintain mean arterial pressure values between 60 mmHg and 65 mmHg to produce an optimal surgical field, this will be done by injection of increments of fentanyl (0.5 μg/kg) up to total dose of 3 μg/kg |
| Total dose of propranolol | Intraoperatively | In case of reflex persistent increase in heart rate (HR) \>100 beats/min, i.v. 0.2 mg increments of propranolol will be given to maintain HR 60-70 beats/min. |
| Total dose of nitroglycerine | Intraoperatively | In case of reduction of mean arterial pressure (MAP), nitroglycerine infusion will be done through adjustment from 0.5 to 10 μg/kg/ min according to patient response. |
| Amount of intraoperative blood loss | Intraoperatively | Amount of intraoperative blood loss (by measuring the volume of blood in suction reservoir minus the normal saline used to wash the surgical field) |
| Degree of pain | 24 hours postoperatively | Each patient will be instructed about postoperative pain assessment with visual analog scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be measured immediately after the operation, then at 2, 12, and 24hrs. |
| Time of 1st analgesia requirement | 24 hours postoperatively | Postoperative analgesia is performed with administration of paracetamol/acetaminophen (1 g three times a day) and visual analog scale (VAS) ≥4 will be managed by IV dose of 25mg pethidine. |
| Total meperidine consumption | 24 hours postoperatively | Total postoperative meperidine consumption will be recorded. |
| Incidence of postoperative side effects | 24 hours postoperatively | Incidence of postoperative side effects such as postoperative nausea and vomiting (PONV), headache, visual disturbances, agitation or somnolence will be recorded. |
Countries
Egypt
Contacts
CONTACTNada A Fathy, MSc
Outcome results
None listed