Pain, Postoperative Clinical Trial
Official title:
The Anesthetic and Analgesic Effects of Intravenous Magnesium Sulphate in Elective Laparoscopic Cholecystectomy
The aim of this double-blind randomized study will be to evaluate the effect an intravenous infusion of magnesium has on recovery outcomes after elective laparoscopic cholecystectomy
Status | Recruiting |
Enrollment | 90 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Adult patents - American Society of Anesthesiologists (ASA) class I-III - elective laparoscopic cholecystectomy Exclusion Criteria: - body mass index (BMI) >35 kg/m2 - systematic use of analgesic agents preoperatively - chronic pain syndromes preoperatively - neurological or psychiatric disease on treatment - pregnancy - severe hepatic or renal disease - drug or alcohol abuse - language or communication barriers lack of informed consent |
Country | Name | City | State |
---|---|---|---|
Greece | General Hospital of Nikea | Piraeus | Attiki, Greece |
Lead Sponsor | Collaborator |
---|---|
Aretaieion University Hospital |
Greece,
Haryalchi K, Abedinzade M, Khanaki K, Mansour Ghanaie M, Mohammad Zadeh F. Whether preventive low dose magnesium sulphate infusion has an influence on postoperative pain perception and the level of serum beta-endorphin throughout the total abdominal hysterectomy. Rev Esp Anestesiol Reanim. 2017 Aug - Sep;64(7):384-390. doi: 10.1016/j.redar.2016.11.009. Epub 2017 Feb 14. English, Spanish. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | time to first request for analgesia | the time for the first patient request for analgesia will be noted | during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively | |
Other | morphine consumption in Post-Anesthesia Care Unit (PACU) | mg of morphine requested during patient PACU stay | immediately postoperatively | |
Other | pethidine consumption in the first 48 hours | patients will be followed for cumulative pethidine consumption for 48 hours postoperatively | 48 hours postoperatively | |
Other | remifentanil requirement during surgery | dose of required remifentanil intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value | intraoperatively | |
Other | number of participants experiencing side effects intraoperatively | patients will be monitored for side-effects of the administered agents intraoperatively | intraoperatively | |
Other | number of participants experiencing side effects postoperatively | patients will be monitored for side-effects of the administered agents postoperatively | 48 hours postoperatively | |
Other | time to emergence | time from desflurane discontinuation to first patient response (eye opening) | end of operation, approximately 1 hour after start of surgery | |
Other | time to extubation | time from desflurane discontinuation to tracheal extubation | end of operation, approximately 1 hour after start of surgery | |
Other | duration of nociception level<25 intraoperatively | nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels<25 suggest adequate intraoperatively analgesia | intraoperatively | |
Primary | pain score on arrival to Post-Anesthesia Care Unit (PACU) | pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" | immediately postoperatively | |
Primary | pain score at discharge from Post-Anesthesia Care Unit (PACU) | pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" | at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively | |
Primary | pain score 24 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" | 24 hours postoperatively |
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