Elective Laparoscopic Cholecystectomy, Sevoflurane Anesthesia
Conditions
Keywords
Anesthesia, pregabalin, sevoflurane, laparoscopic cholecystectomy
Brief summary
Preoperative administration of pregabalin would reduce the end tidal concentration of sevoflurane during laparoscopic cholecystectomy with added beneficial improving of the quality of postoperative analgesia.
Detailed description
laparoscopic cholecystectomy is a painful and stressful surgical procedure. Pregabalin is a lipophilic structural analogue of the inhibitory γ-aminobutyric acid by binding to the presynaptic voltage-gated calcium channels that are widely distributed throughout the central and peripheral nervous system. Pregabalin has anticonvulsant, anxiolytic, sleep-modulating, anti-hyperalgesic, opioid-sparing6 and anti-allodynic properties through inhibition of the release of excitatory neurotransmitters such as glutamate, norepinephrine, serotonin, dopamine and substance P. These unique characteristics make pregabalin as a useful therapeutic for treating neuropathic pain and acute postoperative pain in several models of incisional injury and inflammatory conditions including laparoscopic cholecystectomy.
Interventions
DRUGpregabalin
one capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery
DRUGPlacebo
to receive two identical placebo capsules 1 hr before surgery
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
25 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists class I and II * scheduled for elective laparoscopic cholecystectomy * under sevoflurane anesthesia
Exclusion criteria
* communication barriers * cardiovascular diseases * renal diseases * hepatic diseases * endocrinal diseases * neuropsychiatric diseases * prolonged P-R interval * pregnancy * nursing * hypersensitivity * treated by pregabalin, antidepressant, anticonvulsants, opiates or benzodiazepines during the last week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in the end tidal sevoflurane concentrations | intraoperative every 15 min | End-tidal concentrations of sevoflurane (Et-Sevo) were recorded every 15 min after intubation until the skin closure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative fentanyl supplementations | intraoperative, an expected average of 2 hours | intraoperative fentanyl supplementations |
| quality of tracheal extubation | up to 24 after surgery | The quality of tracheal extubation was evaluated using a 5 - points rating scale: 1, no coughing or straining; 2, very smooth, minimal coughing; 3, moderate coughing; 4, marked coughing or straining; and 5, poor extubation, very uncomfortable |
| postoperative cumulative morphine consumption | up to 24 after surgery | postoperative cumulative morphine consumption |
| hemodynamic parameters | before surgery, after the administration of the study capsules; intraoperative, an expected average of 2 hours, up to 24 after surgery | heart rate and mean arterial blood pressure were recorded before (baseline), 45 min after the administration of the study capsules; every 15 min after intubation until the skin closure and every 15 min for the first hour after extubation. |
| postoperative nausea and vomiting | up to 24 after surgery | nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting) |
| awareness and recall | intraoperative, an expected average of 2 hours | The patients were asked about intraoperative awareness and recall on the second postoperative day by asking three simple questions using standard interview What was the last thing you remembered happening before you went to sleep? What is the first thing you remember happening on waking? Did you dream or have any other experiences whilst you were asleep? |
| postoperative sedation and pain scores | up to 24 after surgery | Postoperative pain VAS scores sedation (four-point verbal rating scores (VRS): awake, drowsy, rousable or deep sleep) |
Countries
Egypt
Outcome results
None listed