Butorphanol
Conditions
Keywords
Analgesia, Remifentanil, Postoperative Pain
Brief summary
To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. The patients were divided into two groups: the butorphanol group (n = 30) and the control group (n = 29). Both groups received TIVA with propofol and remifentanil. Observing two groups of patients on the visual analog scale, the total consumption of rescue analogies, and the confidence of postoperative nausea and vomiting (PONV), and the patient satisfaction score.
Detailed description
To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. The patients were divided into two groups: the butorphanol group (n = 30), who received 0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction, and the control group (n = 29), who received the same volume of normal saline. Both groups received TIVA with propofol and remifentanil. The primary outcome was the visual analogue scale (VAS) score for pain at rest and on movement at 1, 2, 4, 6, 12 and 24 hours after surgery. The secondary outcomes were the total consumption of rescue analgesics, the incidence and severity of postoperative nausea and vomiting (PONV), and the patient satisfaction score.
Interventions
DRUGtartaric acid butorphanol
The group received 0.02 mg/kg tartaric acid butorphanol intravenously over 5 minutes, 30 minutes before anaesthesia induction
DRUGnormal saline
The group received 0.02 mg/kg normal saline intravenously over 5 minutes, 30 minutes before anaesthesia induction
Anaesthesia was induced with 2 mg/kg propofol and 0.6 μg/kg remifentanil and maintained with a target-controlled infusion (TCI) of propofol and remifentanil, using the Marsh and Minto models, respectively.
Sponsors
Wuhan Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
33 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* women patients, aged 18-65 years, with an American Society of Anesthesiologists physical status of I or II * undergoing elective gynaecological laparoscopy for benign diseases
Exclusion criteria
* patients who had an allergy or contraindication to any study drug * had chronic pain or opioid use * had a history of substance abuse or psychiatric disorders * were pregnant or lactating * had a severe cardiovascular, respiratory, renal, hepatic or haematological disease * had a body mass index \>30 kg/m2 * had an inability to understand or cooperate with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale ( VAS ) scores for pain | at 1 hour after surgery | Pain was assessed at 1 hour to evaluate immediate postoperative pain while allowing time to recover from anaesthesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the total rescue analgesic consumption (mg) | within 24 hours after surgery | The total rescue analgesic consumption was calculated by adding the amount of morphine delivered by PCA and any supplemental tramadol given by the nurse for inadequate pain control (VAS \>4) or at the patient's request, ensuring that the total opioid dose was within safe limits. |
| the incidence of postoperative nausea and vomiting(PONV) | within 24 hours after surgery | The incidence of postoperative nausea and vomiting(PONV) was defined as any nausea, vomiting or both |
| the nausea severity of postoperative nausea and vomiting(PONV) | within 24 hours after surgery | The nausea severity was rated on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) |
| patient satisfaction score | at 24 hours after surgery | Patient satisfaction was assessed using a 5-point scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied). |
Countries
China
Outcome results
None listed