None listed
Conditions
Brief summary
Laparoscopic cholecystectomy is a gold standard in treating symptomatic cholelithiasis. One of the major advantages over open cholecystectomy is reduced postoperative pain, although pain still remains the most prevalent complaint in early postoperative hours after laparoscopy. Overall pain after laparoscopic cholecystectomy is, according to localization, divided in three major components: incisional pain (somatic pain), visceral pain (deep intraabdominal pain) and shoulder pain. Incisional pain dominates and is most intense on the day of surgery and on the following day. Interventions before noxious stimulus causing central sensitization may attenuate or block sensitization and reduce acute pain and analgesic consumption. Magnesium, the fourth most common cation in human body is a calcium channel blocker and regulates calcium influx in the cell. N – methyl – D – aspartate (NMDA) receptor is an ionotropic receptor for glutamate and aspartate situated throughout brain and spinal cord and is modulated by a number of endogenous and exogenous compounds. NMDA receptor blockade prevents induction of central sensitization due to peripheral nociceptive stimulation and abolishes the hypersensitivity once it is established. Magnesium is a noncompetitive antagonist of the NMDA receptors and its associated ion channels, and therefore very effective drug in treatment of postoperative pain. The aim of this prospective, randomized study is to determine the effect of two preemptive intravenous low-doses of magnesium sulphate (7.5 mg/kg and 5.0 mg/kg) on early postoperative pain (during the first three hours after surgery) in patients with symptomatic cholelithiasis undergoing laparoscopic cholecystectomy.
Interventions
Patients that satisfy inclusion criteria will be randomly allocated in three groups. In two groups patients will receive magnesium sulphate intravenously in two different dosages once, after anaesthesia induction, prior to surgical incision. One group will receive intravenous bolus 5 mg/kg body weight magnesium sulphate and second group intravenous bolus 7.5 mg/kg body weight magnesium sulphate prior to surgical incision. Magnesium sulphate will be given slowly intravenously, bolus dose in 60 se
Patients that satisfy inclusion criteria will be randomly allocated in three groups. In two groups patients will receive magnesium sulphate intravenously in two different dosages once, after anaesthesia induction, prior to surgical incision. One group will receive intravenous bolus 5 mg/kg body weight magnesium sulphate and second group intravenous bolus 7.5 mg/kg body weight magnesium sulphate prior to surgical incision. Magnesium sulphate will be given slowly intravenously, bolus dose in 60 seconds, in both groups. The anaesthetic management of patients will be standardized. All patients will be premedicated with peroral midazolam (7.5 mg) 45 minutes before surgery. Anaesthesia will be induced with midazolam 0.2 mg/kg and propofol 1.5 mg/kg followed by vecuronium 0.1 mg/kg to facilitate tracheal intubation. Fentanyl in dose of 3 µg/kg will be given before surgical incision and nasogastric tube will be inserted for the duration of procedure. The lungs will be mechanically ventilated with oxygen/nitrous oxide, keeping the end-tidal carbon dioxide between 35 – 40 mmHg. Throughout the procedure, intravenous infusion of 500 - 1.000 ml of Ringer solution will be administered and in case of inadequate muscle relaxation, intermittent bolus of vecuronium 0.04 mg/kg will be added. During laparoscopy, intraabdominal pressure will be maintained at 12 mmHg. Troacar insertion sites would not be infiltrated with local anaesthetic, neither intraperitoneal local anaesthetic will be administered. Postoperative pain would be assesed at rest using visual analog scale (VAS) starting from 0 = no pain at all to 10 = worst pain imaginable. The intensity of postoperative pain would be assessed by an investigator blinded to the patient group. Assessment will be made at 1st,2nd, 3rd, 6th, 9th and 24th postoperative hour. According to score on VAS scale, a bolus dose of intravenous analgesic will be administered. If VAS scores will be 3 or 4, methamizol 2.5g intravenously would be given, if VAS scores will be 5 – 7, diclofenac 75 mg intravenously and if VAS scores will be 8-10, tramadol 1mg/kg body weight intravenously would be given, respectively.
Sponsors
Iva Bacak Kocman
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
patients ASA ( American Society of Anesthesiologists ) I-II undergoing elective laparoscopic cholecystectomy
Exclusion criteria
contraindications to any of the drug used in trial, preexisting neurological or psychiatric illness and hystory of drug and alcochol abuse
Outcome results
None listed