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

Primary Purpose

Hypertensive Disease, Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
SBP 20-30% over baseline
SBP 20-30% under baseline
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertensive Disease focused on measuring analgesia, postoperative;, analgesics opioid;, hyperalgesia;, remifentanil;, hypertension.

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Clinico Pontificia Universidad Catolica

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

SBP 20-30% under baseline

SBP 20-30% over baseline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effects of acute hypertension in pain scores

Full Information

First Posted
January 19, 2013
Last Updated
July 8, 2013
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT01897155
Brief Title
Effect of Acute Arterial Hypertension on Morphine's Requirements and Postsurgical Pain.
Official Title
Effect of Acute Arterial Hypertension on Morphine's Requirements and Postsurgical Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Disease, Pain, Postoperative
Keywords
analgesia, postoperative;, analgesics opioid;, hyperalgesia;, remifentanil;, hypertension.

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBP 20-30% under baseline
Arm Type
Other
Arm Description
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.
Arm Title
SBP 20-30% over baseline
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SBP 20-30% over baseline
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
SBP 20-30% under baseline
Intervention Description
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 Measure Information:
Title
Morphine requirement post laparoscopic cholecystectomy
Description
Measure of morphine consumption during the first 24 postoperative hours in patients undergoing laparoscopic cholecystectomy.
Time Frame
First 24 hours postoperative
Secondary Outcome Measure Information:
Title
Effects of acute hypertension in pain scores
Time Frame
First 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro E Delfino, MD
Organizational Affiliation
Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinico Pontificia Universidad Catolica
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8330024
Country
Chile

12. IPD Sharing Statement

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

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