Effect of Preemptive Ibuprofen and Dexketoprofen in Patients Undergoing Laparoscopic Cholecystectomy

NCT03607266 | Completed

• 1 other identifier: ibupfen
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Laparoscopic Cholecystectomy

Keywords

ibuprofen ,; Preemptive analgesia; laparoscopic cholecystectomy; preemptive

Outcome Measures

Primary Outcomes (1)

• opioid consumption

  Total opioid consumption as microgram/kg will be assessed in 24 hour surgery

  First 24 hours total opioid consumption

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing laparoscopic cholecystectomy

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Celaleddin Soyalp

Van, 65080, Turkey (Türkiye)

Location

Related Publications (1)

• Lee IO, Kim SH, Kong MH, Lee MK, Kim NS, Choi YS, Lim SH. Pain after laparoscopic cholecystectomy: the effect and timing of incisional and intraperitoneal bupivacaine. Can J Anaesth. 2001 Jun;48(6):545-50. doi: 10.1007/BF03016830.

  PMID: 11444448 BACKGROUND

Study Officials

• CELALEDDİN SOYALP

  Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. prof.

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 31, 2018
• Study Start: August 20, 2018
• Primary Completion: September 30, 2022
• Study Completion: December 30, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

TU (1)