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NCT Number: NCT03137615

The Cardiovascular Changes Associated With Septal Local Anaesthesia

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?

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Key information

Conditions

Hypothalamic Neoplasms Anesthesia, Local Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine System Diseases Hypothalamic Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Supratentorial Neoplasms

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pituitary surgery

Procedure

Trans-sphenoidal resection of a pituitary gland lesion.

local anaesthetic injection

Drug

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).

Primary outcomes

  1. Change in blood pressure after administration of local anaesthesia

    Time frame: 5 minutes

    Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.

Secondary outcomes

  1. Change in heart rate after administration of local anaesthesia

    Time frame: 5 minutes

    Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.

  2. Change in cardiac output after administration of local anaesthesia

    Time frame: 5 minutes

    Changes in cardiac output from baseline after infiltration of local anaesthetic.

  3. Change in systemic vascular resistance after administration of local anaesthesia

    Time frame: 5 minutes

    Changes in systemic vascular resistance from baseline after infiltration of local anaesthetic.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 3, 2017
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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