A Comparison of the Effects of Intraoperative Administration of Metoprolol or Esmolol on General Anesthetic Requirement

NCT00756236 | Completed Results DMC

• 1 other identifier: 1638
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

We will compare three study groups receiving metoprolol, esmolol, or placebo. Level of anesthesia will be titrated to achieve the same range of BIS value in all groups. Our hypothesis is that the metoprolol and esmolol groups will require a lower level of anesthetic agent to achieve the targeted BIS range, compared to the placebo group. Our objective is to clarify if metoprolol, in a dose range used for perioperative cardiac protection, decreases anesthetic requirement.

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve of etSEV Over the First Hour

  We will measure the amount of Sevoflurane used to achieve the same level Bispectral Index. Each patient will have their percentage of sevoflurane in expired breath measured every 5 minutes for 2 hours, resulting in 24 data points per person. The primary endpoint will be area under the curve (AUC) for each subject for the first hour.

  Every 5 minutes for 2 hours

Study Arms (3)

M-Group

EXPERIMENTAL

Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.

Drug: Metoprolol

E-Group

EXPERIMENTAL

Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.

Drug: Esmolol

P-Group

PLACEBO COMPARATOR

Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml \& 5ml syringes.

Drug: P-Group

Interventions

Metoprolol DRUG

60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration

Also known as: M-Group

M-Group

Esmolol DRUG

60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl

Also known as: E-Group

E-Group

P-Group DRUG

0.9%NaCl dispensed in 60ml \& 5ml syringes

Also known as: Placebo Comparator

P-Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being older than 18 but, not older than 75
• Scheduled for surgery under general anesthesia
• Duration of surgery scheduled as 2 hours or longer

You may not qualify if:

• Intracranial or intrathoracic surgery (due to difficulty using a BIS monitor or frequent need for beta-receptor antagonism)
• Indication for perioperative beta-receptor antagonism
• Current use of calcium-channel antagonists
• History of coronary artery disease
• History of reactive airway disease
• History of diabetes or other disorders of glucose metabolism
• Reported allergy to any of the study drugs
• Reported substance abuse (except nicotine and caffeine)
• Use of monoamine oxidase (MAO) inhibitor drugs
• Hypersensitivity to metoprolol, esmolol and related derivatives, or to any of the excipients of either.
• Hypersensitivity to other beta-blockers (cross-sensitivity between beta-blockers can occur).
• Sick-sinus Syndrome.
• Heart block greater than first degree, cardiogenic shock, and overt cardiac failure.
• Significant first-degree heart block (P-R interval greater than or equal to 0.24 sec; systolic pressure \< 100mmHg; or moderate- to-severe cardiac failure).
• Severe peripheral arterial circulatory disorders.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology

Oklahoma City, Oklahoma, 73104, United States

Location

Related Links

• University of Oklahoma Health Sciences Center

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Metoprolol; esmolol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Limitations and Caveats

1. Surgical stimulus was not standardized. 2. ß-blockade in Group M was not as uniform as that of Group E. 3. There was considerable variation in achieving the target BIS level.

Results Point of Contact

• Title: Dr. Mehmet Ozcan, MD
• Organization: Department of Anesthesia. OUHSC

mehmet-ozcan@ouhsc.edu

405-271-4351

Study Officials

• Pramod Chetty, MD

  Faculty, Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Study Start: October 1, 2008
• Primary Completion: September 2, 2015
• Study Completion: September 2, 2015
• Last Updated: July 31, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)