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Effect of Preemptive Ibuprofen and Dexketoprofen in Patients Undergoing Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03607266
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Celaleddin Soyalp, Yuzuncu Yıl University

Brief Summary:
The primary aim of this study is to investigate the effects of preventive ibuprofen and dexketoprofen on postoperative opioid requirement in patients undergoing elective laparoscopic cholecystectomy. The secondary aim is to compare routine administration of preemptive ibuprofen and dexketoprofen in terms of intraoperative hemodynamic parameters, postoperative complications, and patient satisfaction

Condition or disease
Laparoscopic Cholecystectomy

Detailed Description:

Study Protocol, Methodology, Procedure: The study will be conducted with 90 patients aged 18-65 years with an ASA score of I and II who are planned for elective laparoscopic cholecystectomy. Patients converted to open surgery during laparoscopy and those with an ASA score of III and IV will be excluded from the study. All the patients will undergo physical examination and laboratory tests 1 day prior to the procedure. On the same day, each patient will be informed about VAS scoring system which is based on a 0-10 scale representing the severity of pain and the patients will be asked to grade their postoperative pain on this scale, where 0 indicates no pain and 10 indicates the most severe pain.

Placebo Group will receive 100 cc of isotonic solution within 30 min before the procedure. Dexketoprofen Group will receive 50 mg iv dexketoprofen in addition to 100 cc of isotonic solution within 30 min before the procedure. Ibuprofen Group will receive 800 mg iv ibuprofen in 100 cc of isotonic solution within 30 min before the procedure. Hemodynamic parameters including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and oxygen saturation (SpO2) will be recorded every 10 min for each patient both preoperatively and throughout the procedure. Additionally, total operative time will be recorded for each patient. The surgical procedure will be performed under general anesthesia. Anesthetic induction will be achieved with iv 2 mg/kg propofol, 2 mcg/kg fentanyl, and 0.6 mg/kg rocuronium. Anesthetic maintenance will be achieved with 8% desflurane, 40% O2, and 1 mcg/kg fentanyl. After the surgery, deep and subcutaneous infiltration of trocar insertion sites will be achieved with 4 cc of 0.5% bupivacaine. Moreover, to antagonize the effects of muscle relaxants, intravenous 0.015 mg/kg atropine and 0.04 mg/kg neostigmine will be administered. Patient-controlled analgesia (PCA) will be adjusted to a bolus dose 25 µg of fentanyl with a maximum of 6 doses/h, lockout interval of 10 min, and no basal infusion.

Postoperative Analgesia: Intravenous PCA will be adjusted to a bolus dose 25 µg of fentanyl with a maximum of 6 doses/h, lockout interval of 10 min, and no basal infusion.

Throughout laparoscopy, an intraabdominal pressure of 12-14 mmHg will be maintained. After the procedure, the patients will be transferred to the recovery room. In the recovery room, patients with a modified Aldrete score of 9 or more will be transferred to the general ward. VAS scores at postoperative 1, 2, 4, 6, 12, and 24 h will be recorded as resting VAS scores. The nurses/physicians recording the VAS scores will be blinded to the analgesic drugs and the patient groups. Patients with a VAS score of ≥4 will receive additional 50 mg tramadol in 100 cc of isotonic solution. Total procedure time will be recorded for each patient. Postoperative events occurring within the first 24 h including nausea, vomiting, mouth dryness, itching, palpitation, and headache will be recorded for each patient. At the end of the procedure, a survey will be performed to assess patient satisfaction regarding postoperative pain and other complications. To achieve this, the patients will be asked to grade their satisfaction on a 1 to 3 scale, in which 1 represents poor, 2 represents fair, and 3 represents good outcome.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effect of Preemptive Ibuprofen and Dexketoprofen on Postoperative Opioid Consumption in Patients Undergoing Laparoscopic Cholecystectomy
Estimated Study Start Date : August 20, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Group I (Ibuprofen)
Ibuprofen Group will receive 800 mg iv ibuprofen in 100 cc of isotonic solution within 30 min before the procedure
Group D (Dexketoprofen
Dexketoprofen Group will receive 50 mg iv dexketoprofen in addition to 100 cc of isotonic solution within 30 min before the procedure
Placebo Group
will receive 100 cc of isotonic solution within 30 min before the procedure



Primary Outcome Measures :
  1. opioid consumption [ Time Frame: First 24 hours total opioid consumption ]
    Total opioid consumption as microgram/kg will be assessed in 24 hour surgery



Information from the National Library of Medicine

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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
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing laparoscopic cholecystectomy
Criteria

Inclusion Criteria:

  • Patients scheduled for elective laparoscopic cholecystectomy.
  • Aged 18-65 years
  • ASA score of I and II.

Exclusion Criteria:

Aged under 18 year Over 65 years Failure to provide a written consent Several cardiac failure, cronic renal failure, Pregnancy, A prior known allergic reaction to the drugs to be administered, Being unable to use patient-controlled analgesia (PCA) pumps, and conversion to open surgery during laparoscopy.


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): NCT03607266


Contacts
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Contact: CELALEDDİN SOYALP +905068456504 c.soyalp@hotmail.com
Contact: YUZKAT NUREDDIN +905052294728 nyuzkat@gmail.com

Locations
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Turkey
Celaleddin Soyalp Recruiting
VAN, Turkey, 65080
Contact: celaleddin soyalp         
Contact: YUZKAT NUREDDIN    +905052294728    nyuzkat@gmail.com   
Sponsors and Collaborators
Yuzuncu Yıl University
Investigators
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Study Chair: CELALEDDİN SOYALP Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey

Publications:
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Responsible Party: Celaleddin Soyalp, Assist. prof., Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03607266     History of Changes
Other Study ID Numbers: ibupfen
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Celaleddin Soyalp, Yuzuncu Yıl University:
ibuprofen ,
Preemptive analgesia
laparoscopic cholecystectomy
preemptive

Additional relevant MeSH terms:
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Ibuprofen
Dexketoprofen trometamol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action