Evaluation of Periop Biochemical Stress Factors in Craniotomy Neurosurgical Procedure With Respect to Preop Hypertension

NCT02441842 | Completed Phase 4

• 1 other identifier: 5820 / 2006
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

Perioperative hypertension is commonly associated with surgical craniotomy. As the sympathetic nervous system and the renin-angiotensin-aldosterone system play a key role in the development of this hypertension, preoperative single dose therapy with a -adrenergic receptor blocker or an angiotensin converting enzyme (ACE) inhibitor may be useful in preventing this. To assess this as well as to study potential markers of these two systems, the investigators will perform a randomized, double blind, placebo controlled study to compare the single dose effect of preoperative administration of a -receptor blocking drug (atenolol) and an ACE inhibitor (lisinopril) with a control group receiving a placebo tablet (glucose) on perioperative hypertension in craniotomy patients.

Conditions

Perioperative Hypertension

Keywords

β-blocker; ACE inhibitor; Stress; Craniotomy; Postop hypertension; neurosurgical patients

Outcome Measures

Primary Outcomes (2)

• MAP changes

  MAP changes associated with preoperative single dosage treatment with atenolol or lisinopril, at the time of dural incision and at extubation, as well as 12 hours postoperatively compared to the control group

  time of incision, extubation and 12 hours postop

• HR changes

  HR changes associated with preoperative single dosage treatment

  time of incision, extubation and 12 hours postop

Secondary Outcomes (2)

• plasma concentrations of vasoactive markers

  12 hours before procedure, during time of dural opening and immediately following extubation

• plasma concentrations of serum sodium levels

  12 hours before procedure, during time of dural opening and immediately following extubation

Study Arms (3)

Group A : Atenolol

ACTIVE COMPARATOR

oral atenolol (50mg)

Drug: atenolol

Group C: Placebo

PLACEBO COMPARATOR

glucose tablet (10mg)

Other: glucose

Group L: Lisinopril

ACTIVE COMPARATOR

oral lisinopril (5mg)

Drug: lisinopril

Interventions

lisinopril DRUG

administered 60 minutes pre procedure

Group L: Lisinopril

glucose OTHER

administered 60 minutes pre procedure

Group C: Placebo

atenolol DRUG

administered 60 minutes pre procedure

Group A : Atenolol

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo craniotomy for a supratentorial brain tumor resection
• Weight between the limits of 70 - 100 kgs

You may not qualify if:

• Weight less than 70 kgs or more thank 100 kgs
• Meds for hypertension
• Evidence of raised intracranial pressure, hypertension, cardiovascular, endocrine or renal disease

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Interventions

Atenolol; Lisinopril; Glucose

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• K.V. Parthiban, PhD

  Christian Medical College, Dept of Neurological Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof; Dir. Acute Pain, Regional Anesthesia/ Orthopedics

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 12, 2015
• Study Start: March 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 8, 2017

Record last verified: 2017-02