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Completed

NCT Number: NCT01897155

Effect of Acute Arterial Hypertension on Morphine's Requirements and Postsurgical Pain.

The purpose of this randomized clinical trial is to evaluate the effect of acute arterial hypertension maintained during surgery on morphine's requirements in patients undergoing laparoscopic cholecystectomy

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Key information

Conditions

Hypertensive Disease Agnosia Cardiovascular Diseases Hyperalgesia Hypertension Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Sensation Disorders Signs and Symptoms Somatosensory Disorders Vascular Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinico Pontificia Universidad Catolica

Santiago, Santiago Metropolitan, 8330024, Chile

About this study

The high arterial blood pressure has been correlated with an increase in pain threshold in animal and humans. One of the explanations to this phenomenon is a baroreceptor activity and vasopressin release at the level of spinal cord dorsal horn and hypothalamus.

As far as we know, there is only one study about the effect of chronic hypertension on postoperative pain and none with acute hypertension. We therefore decided to conduct a randomized controlled trial to evaluate the effect of acute hypertension on postoperative morphine's requirements.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anesthesiology patient classification status(ASA) I-II
  • Between 20 and 60 years of age
  • Programed for elective laparoscopic cholecystectomy

Exclusion criteria

  • History of arterial hypertension
  • Baseline blood pressure over 139/89
  • Use of opioids and any analgesic drug during the last 24 hours before surgery
  • Chronic use of nonsteroidal antiinflammatory
  • BMI > 34.9
  • History of drug or alcohol abuse
  • Use of medications that interfere in the central nervous system
  • Adverse reactions to the drugs used in the study
  • Pregnancy

Treatment and study plan

SBP 20-30% over baseline

Other

Patients were assigned to receive a phenylephrine infusion in order to maintain systolic blood pressure (SBP) 20% to 30% over the baseline. The upper limit of systolic blood pressure is 165 mmHg.

SBP 20-30% under baseline

Other

Patients were assigned to receive a phenylephrine infusion in order to maintain systolic blood pressure (SBP) 20% to 30% below the baseline. The lower limit of systolic blood pressure is 75 mmHg

Primary outcomes

  1. Morphine requirement post laparoscopic cholecystectomy

    Time frame: First 24 hours postoperative

    Measure of morphine consumption during the first 24 postoperative hours in patients undergoing laparoscopic cholecystectomy.

Secondary outcomes

  1. Effects of acute hypertension in pain scores

    Time frame: First 24 hours postoperative

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 11, 2013
Registry last updated
Jul 11, 2013

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.

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