Impact of Glycopyrrolate on Carotid Angioplasty and Stenting

Prophylactic glycopyrrolate vs placebo in carotid angioplasty and stenting for carotid stenosis to prevent bradycardia and/or hypotension and improve post-operative outcome.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000358549

Acronym

GCAS

Enrollment

Registered

2006-08-18

Start date

2006-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aims: Certain patients have a narrowing in the blood vessel that supplies blood to the brain. If this blood vessel gets blocked these patients can suffer a stroke because there is no blood flow to that part of the brain. One method of keeping this blood vessel open is a procedure where a special line is inserted into the blood vessel and a balloon is inflated. Inflating the balloon will cause the blood vessel to get bigger. To make sure that the blood vessel stays open a device called a stent (like a rigid internal pipe) is placed as well. This procedure is called carotid angioplasty and stenting. However, making the blood vessel bigger in this way can activate a nerve which can act on the heart, which can cause the heart rate and blood pressure to change significantly. Glycopyrrolate is a drug which is commonly used to increase a patient’s heart rate. In this study, glycopyrrolate, is given before the balloon is inflated to try to prevent the changes in heart rate and blood pressure. The aims of the study are to see if giving glycopyrrolate can prevent the changes in heart rate and blood pressure as well as improving the outcome of the patient after the procedure. Methodology: Information will be collected on the patient’s medical problems before the procedure. Patients will then be randomised to receive either an injection of glycopyrrolate or water before balloon inflation. Complications during the procedure will be noted such as changes in heart rate, blood pressure and electrocardiograph changes. If the patient does develop changes in heart rate or blood pressure, rescue medications will be available. After the procedure, cardiovascular and neurological complications will be noted. Blinding: Double blind: Non-participating anaesthetist will open a sealed opaque envelope and draw up either glycopyrrolate or water (to an equal volume) and give it to the participating anaesthetist to administer. Neither the patient or the participating anaesthetist will know if the drug is glycopyrrolate or placebo.

Interventions

Glycopyrrolate 1. Dosage of drug: Glycopyrrolate 0.2-0.4mg Frequency: Once only at not less than 6 mins before balloon inflation but not more than 2 hours before balloon inflation Mode: intravenous 2. Intervention group: Receives glycopyrrolate 3. Control group: Receives normal saline (placebo) 4. Duration of intervention: Once only administration of glycopyrrolate given as detailed above.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Healthy volunteers

Inclusion criteria

All patients for carotid angioplasty and stenting.

Exclusion criteria

Inability to consent, patient refusal, allergy to glycopyrrolate.

Outcome results