Calculus of bile duct with cholecystitis. Calculus of bile duct with cholecystitis
Conditions
Interventions
Intervention 1: In the first group, patients undergoing surgery during the first two weeks of each month (from the first day to the end of the 14th day of the month) will receive dexmedetomidine. The
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1- American Society of Anesthesiologists (ASA) physical status I or II. 2-Undergoing elective laparoscopic cholecystectomy under general anesthesia at Imam Ali Hospital in Baghdad. Patients aged ??-?? years Body mass index (BMI) < 35 kg/m²
Exclusion criteria
Exclusion criteria: history of alcohol or substance abuse during past 5 years.(self report) history of seizures.(self report or documented in medical history) History of allergy or to dexmedetomidine or ketamine.(self report or documented in medical history) hepatic, renal, or cardiovascular disease (self report or documented in medical history) Uncontrolled hypertension or history of hypertensive crisis(self report or documented in medical history)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative shivering that will be evaluated and graded by a observer using a standard 5-point clinical scale(Crossley & Mahajan Shivering Scale). Timepoint: In this study, the severity of postoperative shivering will be recorded at four specific time points. The first measurement will be performed immediately after the patient is transferred to the recovery room, simultaneously with emergence from anesthesia and initial awakening, designated as time zero. Subsequent measurements will be performed at 30, 60, and 120 minutes after arrival in the recovery room. Method of measurement: The severity of shivering will be assessed using the standard Crossley Shivering Scale, which grades shivering on a five-point scale from 0 (no shivering) to 4 (very severe and generalized shivering). These time points have been selected based on the peak incidence of shivering during the first 30 to 60 minutes of recovery and its resolution after two hours.;Heart rate (HR) recorded as beats per minute, reflecting the cardiovascular response to anesthetic drugs (dexmedetomidine or ketamine) during and after laparoscopic cholecystectomy. Timepoint: Heart rate will be measured and recorded at the following time points: before induction of anesthesia (baseline value),The first measurement will Before induction, After induction, 5 min after pneumoperitoneum, 15 min after pneumoperitoneum, 30 min after pneumoperitoneum, After Exsufflation, End of surgery. Method of measurement: : Heart rate will be continuously measured using a standard hospital monitor , and values will be recorded manually or automatically at the specified time points on the data collection form. The unit of measurement will be beats per minute (bpm).;Systolic blood pressure (SBP) recorded as the maximum arterial pressure during left ventricular contraction in millimeters of mercury (mmHg), reflecting the cardiovascular response to anesthetic drugs (dexmedetomidine or ketamine) during and after laparoscopic cholecystectom | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative pain intensity assessed and recorded by the patient using the Visual Analog Scale (VAS) ranging from 0 to 10. A score of 0 indicates no pain and a score of 10 indicates the worst imaginable pain. This variable will be used to compare the effectiveness of dexmedetomidine and ketamine in pain control after laparoscopic cholecystectomy. Timepoint: Postoperative pain intensity will be measured and recorded at the following time points: 1, 2, 4, 6, 12, and 24 hours after completion of surgery and transfer of the patient to the recovery room or regular ward. Method of measurement: The Visual Analog Scale (VAS) will be used to assess pain intensity. This scale consists of a straight 10 cm line, with the two ends labeled "no pain" (score 0) and "worst imaginable pain" (score 10). The patient will be instructed to mark a point on this line that represents their current pain intensity. The distance from the marked point to the zero end will be measured in millimeters and recorded as the VAS score (0-10). Measurements will be performed at the specified time points by a trained nurse who is blinded to the type of medication received by the patient (assessor blinding).;Rescue analgesia consumption recorded as the total dose of analgesic medication (in milligrams) and the number of injection doses administered during the first 24 hours after surgery. This variable reflects the patient's need for additional pain relief when the primary study medication (dexmedetomidine or ketamine) provides insufficient analgesia. The rescue analgesic of choice in this study will be morphine (or pethidine/fentanyl depending on hospital protocol). Timepoint: Rescue analgesia consumption will be recorded during the first 24 hours after completion of surgery. Data collection will include cumulative drug consumption at 2, 4, 6, 12, and 24 hours after surgery. Additionally, the number of patient requests for analgesic medication and the number of injections administered by the nurse will | — |
Countries
Iraq
Contacts
Public ContactMohamad Sorani
Tehran University of Medical Sciences
Outcome results
None listed