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Trial record 62 of 116 for:    Atenolol

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

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ClinicalTrials.gov Identifier: NCT02441842
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Sanjib Adhikary, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE May 5, 2015
First Posted Date  ICMJE May 12, 2015
Last Update Posted Date February 8, 2017
Study Start Date  ICMJE March 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • 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
  • HR changes [ Time Frame: time of incision, extubation and 12 hours postop ]
    HR changes associated with preoperative single dosage treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02441842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • plasma concentrations of vasoactive markers [ Time Frame: 12 hours before procedure, during time of dural opening and immediately following extubation ]
    blood sample taken
  • plasma concentrations of serum sodium levels [ Time Frame: 12 hours before procedure, during time of dural opening and immediately following extubation ]
    blood sample taken
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Periop Biochemical Stress Factors in Craniotomy Neurosurgical Procedure With Respect to Preop Hypertension
Official Title  ICMJE Evaluation of Perioperative Biochemical Stress Factors in Craniotomy Neurosurgical Procedure With Respect to Preoperative Hypertension
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Perioperative Hypertension
Intervention  ICMJE
  • Drug: atenolol
    administered 60 minutes pre procedure
  • Drug: lisinopril
    administered 60 minutes pre procedure
  • Other: glucose
    administered 60 minutes pre procedure
Study Arms  ICMJE
  • Active Comparator: Group A : Atenolol
    oral atenolol (50mg)
    Intervention: Drug: atenolol
  • Placebo Comparator: Group C: Placebo
    glucose tablet (10mg)
    Intervention: Other: glucose
  • Active Comparator: Group L: Lisinopril
    oral lisinopril (5mg)
    Intervention: Drug: lisinopril
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2015)
85
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02441842
Other Study ID Numbers  ICMJE 5820 / 2006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanjib Adhikary, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: K.V. Parthiban, PhD Christian Medical College, Dept of Neurological Sciences
PRS Account Milton S. Hershey Medical Center
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP