Blood Pressure Control
Conditions
Keywords
Sphenopalatine ganglion block, Prilocaine, lidocaine, endoscopic hypophysectomy
Brief summary
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.
Detailed description
Pituitary adenoma excision through endoscopic sinus surgery has been evolving over the years. Though less traumatic less traumatic and less invasive than other approaches, hemodynamic variations during several phases of the surgey as nasal dissection pose challenges for anesthesiologists. Regional techniques present appealing options for better control of blood pressure during periods of maximal surgical stimulation, they may as well provide a better surgical field. One of the regional techniques is the sphenopalatine ganglion bock where a local anesthetic is injected in the pterygopalatine fossa around the sphenopalatine ganglion. Thus, It blocks pain transmission through the branches of the trigeminal nerve. The current study was designed to compare the effects of two local anesthetics, lidocaine versus prilocaine on intraoperative hemodynamics, surgical field and analgesia.
Interventions
Sphenopalatine ganlion block with 2ml of 2% lidocaine and 0.5ml of diluted adrenaline after general anesthesia in patients undergoing enoscopic hypophysectomy.
PROCEDURESphenopalatine Ganglion Block
Sphenopalatine ganlion block with will receive 2ml of 4% prilocaine and 0.5ml saline after general anesthesia in patients undergoing enoscopic hypophysectomy.
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients with pituitary adenoma undergoing endoscopic hypophysectomy. * ASA physical status I and II. * Age above 21, below 45 years. * Male or female
Exclusion criteria
* Any patient below 21 years or above 45 years. * Patients suffering from any of the following conditions: * Disturbed conscious level. * Coagulation abnormalities. * Poorly controlled blood pressure and/or heart rate. * Increased intracranial tension. * Liver and kidney disorders. * Patients on anticoagulants and/or NSAIDS (non-steroidal anti- inflammatory drugs * Patients addicted to drugs and/or alcohol. * Patients with disturbed conscious level at the end of the surgery, GCS \>14
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAP | Mean arterial blood pressure in mmhg in the intraoperative period 5 minutes after nasal dissection | mean arterial blood pressure in the intraoperative period 5 minutes after nasal dissection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | 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. | 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. |
| Diastolic blood preesure | 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. | 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. |
| HR | 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. | 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. |
| Patients needing propranolol | The number of patients throughout the study in the intraoperative period who received propranolol | The number of patients needing propranolol in each group. |
| Propranolol needed | The amount of propranolol in mg used throughout the surgery in each group | The total amount of propranolol in mg used in each group |
| Patients needing phentolamine | The number of patients receiving phentolamine throughout the surgery in both groups | The number of patients needing phentolamine in each group. |
| Mean arterial 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. | 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. |
| Surgeon satisfaction scale | 10 minutes after the end of surgery. | Surgeon satisfaction scale based on Average category scale (ACS) from 0 to 5 with 0 meaning no bleeding and 5 massive uncontrollable bleeding |
| Time to 1st analgesic requirement | The time in hours from emergence of anaesthesia till the request of first rescue analgesia in the first 24 hours after surgery | The time from emergence of anaesthesia till the request of first rescue analgesia |
| Blood loss | Throughout the surgical time from the begining to the end of surgery | The total ammount of blood loss in cc |
| Requirement for transfusion | Throughout the surgical time from the begining to the end of surgery | The number of patients requiring transfusion |
| Fentanyl needed | Throughout the surgical time from the begining to the end of surgery | number of patients needing fentanyl boluses intraoperatively |
| Total amount of fentanyl | Throughout the surgical time from the begining to the end of surgery | total ammount of fentanyl needed in micrograms |
| Phentolamine needed | Throughout the surgical time from the begining to the end of surgery | The total amount of phentolamine in mg used in each group. |
Countries
Egypt
Contacts
Primary ContactRania Fahmy, Associate Professor
Outcome results
None listed