Health TrialsbyHealthPanel

Prilocaine for Sphenopalatine Ganglion Block in Endoscopic Hypophysectomy

ConditionBlood Pressure Control
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-45
SponsorKasr El Aini Hospital

About this trial

Patients undergoing endoscopic surgeries for pituitary adenoma excision suffer from wide swings in blood pressure that might increase bleeding and interfere with the surgical field.

Local anethetic infiltration and regional nerve blocks have been used to provide better analgesia, control blood pressure and improve surgical field.

Limited studies evaluated shenopalatine ganglion block in pituitary adenoma excision with promising outcomes. The proposed study will compare the efficacy of two local anesthetics, prilocaine and lidocaine, for spenopalatine ganglion block in patients undergoing endoscopic pituitary adenoma excision. Evaluating the control of the intraoperative blood pressure and analgesic sparing are the main objectives of the proposed study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with pituitary adenoma undergoing endoscopic hypophysectomy.

ASA physical status I and II.

Age above 21, below 45 years.

Male or female

Disqualifiers

Any patient below 21 years or above 45 years.

Disturbed conscious level.

Coagulation abnormalities.

Poorly controlled blood pressure and/or heart rate.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sphenopalatine Ganglion Block using 2% lidocaine

    Procedure/Surgery

    Sphenopalatine ganlion block with 2ml of 2% lidocaine and 0.5ml of diluted adrenaline after general anesthesia in patients undergoing enoscopic hypophysectomy.

  • Sphenopalatine Ganglion Block

    Procedure/Surgery

    Sphenopalatine ganlion block with will receive 2ml of 4% prilocaine and 0.5ml saline after general anesthesia in patients undergoing enoscopic hypophysectomy.

  • Sphenopalatine Ganglion Block

    Procedure/Surgery

    Sphenopalatine ganlion block with will receive 2ml of 4% prilocaine in addition to 0.5ml of diluted adrenaline. after general anesthesia in patients undergoing enoscopic hypophysectomy.

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: Group Lidocaine (L)Active comparator 1 intervention
Group B: Group Prilocaine (P)Experimental treatment 1 intervention
Group C: Group Prilocaine adrenaline (PA)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MAP

mean arterial blood pressure in the intraoperative period 5 minutes after nasal dissection

Time frame
Mean arterial blood pressure in mmhg in the intraoperative period 5 minutes after nasal dissection
2

MAP

mean arterial blood presssure 5 minutes after nasal dissection

Time frame
Mean arterial blood pressure in mmhg after 5 minutes of nasal dissection

Secondary outcomes

1

Mean arterial blood pressure

Mean arterial blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.

Time frame
Before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
2

Systolic blood pressure

Systolic blood pressure before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.

Time frame
Systolic blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
3

Diastolic blood preesure

Diastolic blood pressure before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.

Time frame
Diastolic blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
4

HR

Heart rate before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.

Time frame
Heart rate in beats/min before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kasr El Aini Hospital

Lead sponsor

Source ClinicalTrials.gov
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