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

NCT01897155 | Completed Phase 4

• 1 other identifier: RIH_AP-UC-2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertensive Disease; Pain, Postoperative

Keywords

analgesia, postoperative;; analgesics opioid;; hyperalgesia;; remifentanil;; hypertension.

Outcome Measures

Primary Outcomes (1)

• Morphine requirement post laparoscopic cholecystectomy

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

  First 24 hours postoperative

Secondary Outcomes (1)

• Effects of acute hypertension in pain scores

  First 24 hours postoperative

Study Arms (2)

SBP 20-30% under baseline

OTHER

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

SBP 20-30% over baseline

OTHER

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

Interventions

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

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

SBP 20-30% over baseline

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clinico Pontificia Universidad Catolica

Santiago, Santiago Metropolitan, 8330024, Chile

Location

MeSH Terms

Conditions

Hypertension; Pain, Postoperative; Agnosia; Hyperalgesia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Somatosensory Disorders; Sensation Disorders

Study Officials

• Alejandro E Delfino, MD

  Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2013
• First Posted: July 11, 2013
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: July 11, 2013

Record last verified: 2013-06

Locations

CL (1)