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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the butorphanol group | Experimental | 0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction. |
|
| the control group | Placebo Comparator | 0.02 mg/kg of normal saline intravenously 30 minutes prior to anaesthesia induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tartaric acid butorphanol | Drug | The group received 0.02 mg/kg tartaric acid butorphanol intravenously over 5 minutes, 30 minutes before anaesthesia induction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale ( VAS ) scores for pain | Pain was assessed at 1 hour to evaluate immediate postoperative pain while allowing time to recover from anaesthesia. | at 1 hour after surgery |
| Visual analogue scale ( VAS ) scores for pain | Pain was assessed at 2 hours after surgery. | at 2 hours after surgery |
| Visual analogue scale ( VAS ) scores for pain | Pain was assessed at 4 hours after surgery. | at 4 hours after surgery |
| Visual analogue scale ( VAS ) scores for pain | Pain was assessed at 6 hours after surgery. | at 6 hours after surgery |
| Visual analogue scale ( VAS ) scores for pain | Pain was assessed at 12 hours after surgery. | at 12 hours after surgery |
| Visual analogue scale ( VAS ) scores for pain | Pain was assessed at 24 hours after surgery. | at 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| the total rescue analgesic consumption (mg) | 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. | within 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Children's hospital | Wuhan | China |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D015742 | Propofol |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| normal saline | Drug | The group received 0.02 mg/kg normal saline intravenously over 5 minutes, 30 minutes before anaesthesia induction |
|
| propofol and remifentanil | Drug | 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. |
|
| the incidence of postoperative nausea and vomiting(PONV) | The incidence of postoperative nausea and vomiting(PONV) was defined as any nausea, vomiting or both | within 24 hours after surgery |
| the nausea severity of postoperative nausea and vomiting(PONV) | The nausea severity was rated on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) | within 24 hours after surgery |
| patient satisfaction score | Patient satisfaction was assessed using a 5-point scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied). | at 24 hours after surgery |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |