The Cardiovascular Changes Associated With Septal Local Anaesthesia

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects on the heart of injecting local anaesthetic into the nose prior to surgery on the pituitary gland?

Detailed Description
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People sometimes require surgery on their pituitary gland. This is a gland at the base of your brain which secretes hormones. At the Royal Hallamshire Hospital the investigators are currently conducting a study into the effects of local anaesthetic (a medicine which causes numbness) injection on patients undergoing this particular type of operation. After patients are anaesthetised (asleep) but before surgery starts the surgeon injecst a local anaesthetic solution into the nose. This is routine practice and is done to provide pain relief afterwards and also to decrease the amount of bleeding during the operation to ensure that the surgeon has a good view. The investigators have known for a long time that local anaesthetic affects the heart rate and blood pressure, however the investigators would like to describe exactly how, in much more detail.

Official Title
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An Observational Study of the Cardiovascular Response to Infiltration of Local Anaesthetic Into the Nasal Septum in Patients Undergoing Trans-sphenoidal Resection of a Pituitary Lesion

Conditions
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Hypothalamic Neoplasms, Pituitary Diseases, Anesthesia, Local

Intervention / Treatment
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* Procedure: Pituitary surgery
* Drug: local anaesthetic injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any adult patient undergoing trans-sphenoidal pituitary surgery. Exclusion Criteria: Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pituitary Surgery<br>Patients having pituitary gland surgery Inclusion criteria - Any adult patient undergoing trans-sphenoidal pituitary surgery. Exclusion criteria - Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery | Procedure: Pituitary surgery<br>* Trans-sphenoidal resection of a pituitary gland lesion.<br>Drug: local anaesthetic injection<br>* The surgeon infiltrates the nasal septum with local anaesthesia as per usual practice. This consists of Moffet's solution and lidocaine with adrenaline (1:200,000).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure after administration of local anaesthesia | Changes in mean arterial pressure from baseline after infiltration of local anaesthetic. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate after administration of local anaesthesia | Changes in mean arterial pressure from baseline after infiltration of local anaesthetic. | 5 minutes | 
| Change in cardiac output after administration of local anaesthesia | Changes in cardiac output from baseline after infiltration of local anaesthetic. | 5 minutes | 
| Change in systemic vascular resistance after administration of local anaesthesia | Changes in systemic vascular resistance from baseline after infiltration of local anaesthetic. | 5 minutes |