The Cardiovascular Changes Associated With Septal Local Anaesthesia

Overview

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?

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2015

Detailed Description

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.

Interventions

  • Procedure: Pituitary surgery
    • Trans-sphenoidal resection of a pituitary gland lesion.
  • Drug: local anaesthetic injection
    • 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).

Arms, Groups and Cohorts

  • Pituitary Surgery
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • Change in cardiac output after administration of local anaesthesia
    • Time Frame: 5 minutes
    • Changes in cardiac output from baseline after infiltration of local anaesthetic.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 17 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sheffield Teaching Hospitals NHS Foundation Trust
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Matthew D Wiles, FRCA FFICM, Study Chair, Sheffield Teaching Hospitals NHS Foundation Trust

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.