Skip to main content
OpenTrials
Completed

NCT Number: NCT02441842

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

All patients included in the study will be visited 12 hours preoperatively for determination of base-line (preoperative) blood pressure and heart rate, at which time a blood sample will be taken and the patients will be randomized. The next day, sixty minutes prior to surgery, all patients will receive oral diazepam (10mg) and the blinded study medication. This medication was previously prepared by an independent pharmacist, and dispensed in appropriate packaging. Thus, Group C, the control group, will receive a glucose tablet (10mg), Group A, will receive oral atenolol (50mg) and Group L will receive oral lisinopril (5mg). An intravenous cannula will be placed and normal saline will be infused at the rate of 60 - 70 ml/hr. Haemodynamics (blood pressure and heart rate) will be monitored using a multichannel monitor (and the patient's radial artery (non-dominant arm) will be cannulated for further blood sampling and blood pressure monitoring (Agilent Technologies, MA, USA). Anaesthesia will beinduced with thiopental (4-5 mg.kg-1) and fentanyl, (1-2μg.kg-1). Vecuronium, (0.06-0.1 mgkg-1) will be administered to facilitate tracheal intubation and to maintain neuromuscular blockade. Isoflurane (0.7 - 1.2 MAC) will be administered to maintain the Bispectral Index (BIS) (Aspect Medical System Inc, MA, USA), within the range of 35 - 45. End tidal CO2 partial pressure will be maintained between 4-4.6 kPa (IntelliVue Anesthetic Gas Modules-G1, Redmond, WA, USA). During the surgery, intravenous fentanyl and vecuronium will be administered at the discretion of the anaesthetist for pain control and muscle relaxation respectively. An increase in mean arterial pressure (MAP) in excess of 20% of the pre-operative value will be treated either by increasing the inspired isoflurane concentration or by administering metoprolol. Additionally, a decrease in MAP exceeding 20% will be treated by reducing the isoflurane inspired concentration or by the administration of ephedrine in small doses (2.5-4mg). Ondansetron (4mg) will be administered 45 minutes before the expected conclusion of surgery and neuromuscular agents will be reversed using 2.5 mg of neostigmine and 0.4 mg of glycopyrrolate at the end of skin suturing. Isoflurane will be discontinued at the last suture, and patients will be extubated when they respond to verbal stimulation or coughed. The total amount and type of fluids administered during the procedure will be recorded.

The MAP, HR, end-tidal isoflurane, and end tidal CO2 will be recorded every 10 min following induction until extubation, and MAP and HR only, every 30 min after admission to the neuro-intensive care unit for 12 hrs. These data will be collected from the monitors using printouts after each case and the anesthesia record will also be photocopied. Postoperative pain will be treated with paracetamol (1gm) administered rectally every 6 hrs and morphine injection (2.5mg) intravenously as required.

Hypertension is defined as any mean arterial blood pressure (MAP) more than 20% of the preoperative value (determined 12hrs before the surgery, vide supra).

Blood samples (3 ml) will be collected from each patient pre operatively from venapuncture (12hrs before the surgery), and intra-operatively at the time of dural opening, and immediately after extubation, via the arterial line. Collected blood samples will immediately be centrifuged and stored at -70°C for analysis of plasma renin, aldosterone, norepinephrine, and serum sodium concentrations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Atenolol

Drug

administered 60 minutes pre procedure

Lisinopril

Drug

administered 60 minutes pre procedure

Glucose

Other

administered 60 minutes pre procedure

Primary outcomes

  1. MAP changes

    Time frame: time of incision, extubation and 12 hours postop

    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

  2. HR changes

    Time frame: time of incision, extubation and 12 hours postop

    HR changes associated with preoperative single dosage treatment

Secondary outcomes

  1. plasma concentrations of vasoactive markers

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

    blood sample taken

  2. plasma concentrations of serum sodium levels

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

    blood sample taken

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Evaluation of Perioperative Biochemical Stress Factors in Craniotomy Neurosurgical Procedure With Respect to Preoperative Hypertension

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 12, 2015
Registry last updated
Feb 8, 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.

Published trials that share one or more normalized conditions with this study.