Sphenopalatine Ganglion Block as Adjuvant to General Anesthesia Regarding the Quality of Surgical Field in Trans-Sphenoidal Endoscopic Hypophysectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sphenopalatine ganglion block using bupivacaine + dexamethasone

    Drug

    Patients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone.

  • General anesthesia

    Other intervention

    Patients will receive general anesthesia alone.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of surgical field visibility

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

Time frame
Intraoperatively

Secondary outcomes

1

Intraoperative fentanyl consumption

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

Time frame
Intraoperatively
2

Total dose of propranolol

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.

Time frame
Intraoperatively
3

Total dose of nitroglycerine

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.

Time frame
Intraoperatively
4

Amount of intraoperative blood loss

Amount of intraoperative blood loss (by measuring the volume of blood in suction reservoir minus the normal saline used to wash the surgical field)

Time frame
Intraoperatively

Other outcomes

Sponsors and contacts

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