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Trial record 59 of 761 for:    region | Chile

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

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ClinicalTrials.gov Identifier: NCT01897155
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hypertensive Disease Pain, Postoperative Other: SBP 20-30% over baseline Other: SBP 20-30% under baseline Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Acute Arterial Hypertension on Morphine's Requirements and Postsurgical Pain.
Study Start Date : January 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
SBP 20-30% under baseline
Induction of anesthesia was performed with remifentanil, pentothal 3 mg/kg and atracurium 0.5 mg/Kg. Anaesthesia was maintained with remifentanil (0.4 ug/Kg/min) and isoflurane adjusted to bispectral index (40-60). Patients received a phenylephrine infusion to maintain systolic blood pressure (SBP) 20% to 30% under baseline. The lower limit of SBP was 75 mmHg. In the recovery room, morphine was administered routinely at doses of 3 mg IV every 15 minutes until pain was less than 4 estimated by visual analog scale (VAS). VAS and pain threshold with von Frey filaments were assessed at 2, 6, 12 and 24 postoperative hours. All patients, received ketorolac 30 mg IV every 8 hours and intravenous morphine administered by patient controlled analgesia system (PCA) during the first 24 hours.
Other: SBP 20-30% over baseline
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% over baseline
Induction of anesthesia was performed with remifentanil, pentothal 3 mg/kg and atracurium 0.5 mg/Kg. Anaesthesia was maintained with remifentanil (0.4 ug/Kg/min) and isoflurane adjusted to bispectral index(40-60). Patients received a phenylephrine infusion in order to maintain systolic blood pressure (SBP) 20% to 30% over baseline. The upper limit of SBP was 165 mmHg. In the recovery room, morphine was administered routinely at doses of 3 mg IV every 15 minutes until pain was less than 4 estimated by visual analog scale (VAS). VAS and pain threshold with von Frey filaments were assessed at 2, 6, 12 and 24 postoperative hours. All patients, received ketorolac 30 mg IV every 8 hours and intravenous morphine administered by patient controlled analgesia system (PCA) during the first 24 hours.
Other: SBP 20-30% under baseline
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 Outcome Measures :
  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 Outcome Measures :
  1. Effects of acute hypertension in pain scores [ Time Frame: First 24 hours postoperative ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897155


Locations
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Chile
Hospital Clinico Pontificia Universidad Catolica
Santiago, Region Metropolitana, Chile, 8330024
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Alejandro E Delfino, MD Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01897155     History of Changes
Other Study ID Numbers: RIH_AP-UC-2012
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: June 2013

Keywords provided by Pontificia Universidad Catolica de Chile:
analgesia, postoperative;
analgesics opioid;
hyperalgesia;
remifentanil;
hypertension.

Additional relevant MeSH terms:
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Hypertension
Pain, Postoperative
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Remifentanil
Benzocaine
Phenylephrine
Oxymetazoline
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents