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QUALITY OF RECOVERY AFTER INTRAOPERATIVE MORPHINE OR METHADONE

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ClinicalTrials.gov Identifier: NCT03045133
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Eduardo Toshiyuki Moro, Pontificia Universidade Catolica de Sao Paulo

Brief Summary:
Introduction. Despite the advantages associated with the use of remifentanil during total intravenous anesthesia (TIVA), it has been observed a frequent difficulty in the control of postoperative pain due to the risk of developing hyperalgesia and acute tolerance associated with the administration of this opioid. There is evidence that NMDA receptors are involved in the development of these changes. Methadone is an opioid that exhibits analgesic potency similar to that of morphine but has NMDA antagonist activity and longer duration of action as additional features. The objective of the study was to evaluate the quality of recovery (QoR40) of patients undergoing TIVA for laparoscopic cholecystectomy and who received morphine or methadone to control postoperative pain. Methods. Patients aged 18 to 65 years, physical status ASA I and II, submitted to total venous anesthesia (propofol and remifentanil) for laparoscopic cholecystectomy and eligible to participate in this prospective and randomized clinical study will be evaluated. After induction of anesthesia, patients will receive a solution containing 0.1 mg.kg-1 morphine (MF group) or 0.1 mg.kg-1 methadone (MT group). Data on the presence of pain, nausea, vomiting, tremor, drowsiness, presence of SpO2 <92%, even with O2 face mask (5 L.min-1) and length of stay will be recorded at PACU. The pain will be evaluated every 15 minutes on a verbal numerical scale (ENV) from 0 to 10. E.v. morphine 0.1 mg.kg-1 (MF group) or methadone 0.1 mg.kg-1 (MT group) will be administered every 15 minutes to obtain the score below 3. After discharge from the PACU, all patients will receive intravenous ketoprofen every 12 hours and dipyrone every 6 hours. For cases where the patient considers the analgesic regimen insufficient, tramadol (100 mg) will be administered intravenously at 8-hour intervals. The consumption of analgesics, the intensity of pain, the occurrence of nausea, vomiting and other complications in the ward will be recorded. The application of the questionnaire (QoR40) will be performed in the ward the morning after the surgery by a medical student.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Nausea and Vomiting, Postoperative Drug: Methadone Drug: Morphine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, double-blinded trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Group assignments were sealed in sequentially numbered opaque envelopes that were opened after patient inclusion in the study. All care providers, researchers, and patients were blinded to group assignments. Study 10-mL syringes will be prepared by an anesthesiologist independent of the study. Methadone 0.1 mg.kg-1 (made up to 10 mL with normal saline) or morphine 0.1 mg.kg-1 (made up to 10 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope is opened.

The baseline QoR-40 questionnaire will be provided to subjects after informed consent is obtained in the preoperative holding area and 24 hours after surgery by a blinded investigator.

Primary Purpose: Prevention
Official Title: QUALITY OF RECOVERY AFTER INTRAOPERATIVE MORPHINE OR METHADONE IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY
Actual Study Start Date : June 20, 2016
Actual Primary Completion Date : July 20, 2016
Actual Study Completion Date : April 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MT group
Immediately after the induction of anesthesia, patients will receive intravenously methadone 0.1 mg/kg
Drug: Methadone
Immediately after the induction of anesthesia, patients will receive intravenously methadone 0.1 mg/kg

Active Comparator: MF group
Immediately after the induction of anesthesia, patients will receive intravenously morphine 0.1 mg/kg
Drug: Morphine
Immediately after the induction of anesthesia, patients will receive intravenously morphine 0.1 mg/kg




Primary Outcome Measures :
  1. Quality of recovery (QoR-40) [ Time Frame: 24 hours ]
    The baseline QoR-40 questionnaire will be provided to subjects after informed consent is obtained in the preoperative holding area and 24 hours after surgery by a blinded investigator. The QoR-40 questionnaire assesses five dimensions of recovery (physical comfort - 12 items; emotional state - 7 items; physical independence - 5 items; physiological support - 7 items; and pain - 7 items). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).


Secondary Outcome Measures :
  1. Time to eye opening [ Time Frame: 30 minutes ]
    The time elapsed from discontinuation of the anesthetics until the eye opening

  2. Postoperative pain (PACU) [ Time Frame: 2 hours ]
    Pain will be assessed while at rest and after asking the subjects to cough, every 15 minutes using a 0-10 numeric pain rating scale (NRS), where zero meant no pain and 10 the worst imaginable pain.

  3. Postoperative pain (Ward) [ Time Frame: 24 hours ]
    Subjects will rate the higher score of pain (NRS) during the hospital ward stay

  4. Tramadol consumption [ Time Frame: 24 hours ]
    Consumption, or not, of tramadol during the hospital ward stay

  5. Postoperative nausea and vomiting [ Time Frame: 24 hours ]
    Number of episodes of vomiting or the occurrence of nausea

  6. Time of PACU staying [ Time Frame: 3 hours ]
    Time required to meet and achieve PACU discharge criteria (Aldrete 9)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I or II, who will be scheduled to undergo laparoscopic cholecystectomy at Santa Lucinda Hospital

Exclusion Criteria:

  • Patients who (i) refuse to participate in the study; (ii) are not able to communicate due to alterations in the level of consciousness, or neurologic, or psychiatric disease; - present with contraindication to any of the drugs used in the present study
  • have history of alcohol or drug abuse
  • present a body mass index (BMI) ≥ 40 will be excluded.
  • Reasons for exclusion after randomization will be protocol violations or if the surgical procedure changes from a laparoscopic to an open approach.

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): NCT03045133


Locations
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Brazil
Santa Lucinda Hospital
Sorocaba, SP, Brazil, 18030-230
Sponsors and Collaborators
Pontificia Universidade Catolica de Sao Paulo
Investigators
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Principal Investigator: Eduardo T Moro, Professor PUC São Paulo University

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Responsible Party: Eduardo Toshiyuki Moro, Professor, Pontificia Universidade Catolica de Sao Paulo
ClinicalTrials.gov Identifier: NCT03045133     History of Changes
Other Study ID Numbers: PUCSP 050539/2016
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eduardo Toshiyuki Moro, Pontificia Universidade Catolica de Sao Paulo:
Postoperative pain
Postoperative nausea and vomiting
Quality of recovery
QoR-40
Total intravenous anesthesia
Additional relevant MeSH terms:
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Nausea
Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Morphine
Methadone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents