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N/A Completed N=60 Randomized Quadruple-blind Other

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

Source: ClinicalTrials.gov NCT00756236 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Area Under the Curve of etSEV Over the First Hour — 1.77; 1.46; 1.73 percent*hour

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Curve of etSEV Over the First Hour
1.77; 1.46; 1.73

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00756236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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