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

NCT ID: NCT00756236

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2015-09-02

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.

Detailed Description

Beta-receptor antagonists are commonly used in the perioperative setting. These agents have been shown to decrease the incidence of perioperative myocardial ischemia and are recommended by a recent practice guideline in certain patient groups.1 Besides protection from ischemia, there are other situations where beta-receptor antagonists are used intraoperatively such as control of the sympathetic response to tracheal intubation and certain types of surgical stimuli.

There is new evidence suggesting that administration of esmolol, a short-acting beta-receptor antagonist, might reduce the actual anesthetic requirement. This was initially shown by studies in which esmolol decreased the amount of anesthetic required to prevent movement after skin incision.2;3 Subsequent studies used bispectral index (BIS) as an endpoint and demonstrated decreased BIS values in subjects receiving esmolol during general anesthesia. 4;5

This anesthetic-sparing effect observed with esmolol has not been prospectively studied with other beta-receptor antagonists. Since perioperative beta-blockade is commonly achieved using longer acting agents such as metoprolol or atenolol, it is clinically relevant to understand the effects of these medications on anesthetic requirement. We aim to conduct a prospective, randomized, controlled, double-blind study to compare the anesthetic-sparing effect of metoprolol and esmolol administered intraoperatively.

Conditions

Myocardial Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

M-Group

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.

Group Type: EXPERIMENTAL

Metoprolol

Intervention Type: DRUG

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

E-Group

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.

Group Type: EXPERIMENTAL

Esmolol

Intervention Type: DRUG

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

P-Group

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.

Group Type: PLACEBO_COMPARATOR

P-Group

Intervention Type: DRUG

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

Interventions

Metoprolol

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

Intervention Type: DRUG

Esmolol

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

Intervention Type: DRUG

P-Group

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

Intervention Type: DRUG

Other Intervention Names

M-Group; E-Group; Placebo Comparator

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.
• Pheochromocytoma.
• Baseline heart rate of < 60
• Systolic pressure less than 100 mm Hg
• Pregnant women
• Prisoners

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pramod Chetty, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty, Anesthesiology

Locations

Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology

Oklahoma City, Oklahoma, United States

Countries

United States

Related Links

http://www.ouhsc.edu

University of Oklahoma Health Sciences Center

Other Identifiers

1638

Identifier Type: -

Identifier Source: org_study_id