Wuhan Children's hospital
Wuhan, China
NCT Number: NCT06524596
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.
Looking for future studies?
Notify Me33 year–50 year
Female
Interventional
Not applicable
Wuhan, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The group received 0.02 mg/kg tartaric acid butorphanol intravenously over 5 minutes, 30 minutes before anaesthesia induction
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.
Time frame: at 1 hour after surgery
Pain was assessed at 1 hour to evaluate immediate postoperative pain while allowing time to recover from anaesthesia.
Time frame: at 2 hours after surgery
Pain was assessed at 2 hours after surgery.
Time frame: at 4 hours after surgery
Pain was assessed at 4 hours after surgery.
Time frame: at 6 hours after surgery
Pain was assessed at 6 hours after surgery.
Time frame: at 12 hours after surgery
Pain was assessed at 12 hours after surgery.
Time frame: at 24 hours after surgery
Pain was assessed at 24 hours after surgery.
Time frame: 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.
Time frame: within 24 hours after surgery
The incidence of postoperative nausea and vomiting(PONV) was defined as any nausea, vomiting or both
Time frame: within 24 hours after surgery
The nausea severity was rated on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe)
Time frame: 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).
Wuhan Children's Hospital
Other
Wuhan Children's Hospital
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07724678
Agnosia, Breast Cancer
Altındağ, Ankara, Turkey (Türkiye)
View Trial DetailsNCT07720440
Agnosia, Behavior
Istanbul, Sultangazi, Turkey (Türkiye)
View Trial DetailsNCT07502833
Agnosia, Nervous System Diseases
Ankara, Türkiye, Turkey (Türkiye)
View Trial DetailsNCT07043621
Agnosia, Craniotomy Surgery
Adapazarı, Sakarya, Turkey (Türkiye)
View Trial Details