The Cardiovascular Changes Associated With Septal Local Anaesthesia

NCT ID: NCT03137615

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-06-30

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.

Conditions

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Hypothalamic Neoplasms Pituitary Diseases Anesthesia, Local

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Pituitary surgery

Intervention Type PROCEDURE

Trans-sphenoidal resection of a pituitary gland lesion.

local anaesthetic injection

Intervention Type 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).

Interventions

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Pituitary surgery

Trans-sphenoidal resection of a pituitary gland lesion.

Intervention Type PROCEDURE

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).

Intervention Type DRUG

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.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew D Wiles, FRCA FFICM

Role: STUDY_CHAIR

Sheffield Teaching Hospitals NHS Foundation Trust

Other Identifiers

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STH17059

Identifier Type: -

Identifier Source: org_study_id

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