NCT03810391

Using Preoperative Anxiety Score to Determine the Total Dose of Butorphanol for Sedation

Using Preoperative Anxiety Score to Determine the Total Dose of Butorphanol for Sedation in Patients Undergoing Lower Limb Orthopedic Procedures: A Randomized, Double-blind, Placebo-controlled Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Orthopedic surgeries are considered to be discomfortable and the sense of fear and anxiety of patients who already have preoperative anxiety may be aggravated by intraoperative stimulation, which may contribute to postoperative complications. Previous studies have found that high anxiety predicts increased sedative requirements. Therefore, the investigators explored the relationship between anxiety and intraoperative butorphanol requirements and the investigators evaluated the specific sedative requirement which can keep satisfactory sedative state for patients by preoperative anxiety score

Detailed description

A total of one hundred and eighteen patients who were to undergoing lower limb orthopedic procedures with spinal anesthesia were selected，the Amsterdam preoperative anxiety and information scale was used to evaluated the degree of preoperative anxiety one day before the surgery. Patients in preoperative anxiety group were randomly allocated to two groups: butorphanol group (Group A) and physiological saline group (Group B); Patients in non-preoperative anxiety group were also randomly allocated to two groups: butorphanol group (Group C) and physiological saline group (Group D). In Group A and Group C, patients received an intravenous loading dose of 15ug/kg butorphanol 5 min before starting the surgery, then followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion until the Ramsay sedation score reached 4 points, Group B and Group D received an infusion of the same volume of physiological saline. The sedation scores were recorded 10 min after getting into the operation room and 5, 10, 15, 30min after infusion of butorphanol or physiological saline. The duration when Ramsay sedation score reached 4 points in Group A and C, adverse events and post-operative visual analgesia scale scores were also recorded and compared.

Conditions

• Preoperative Anxiety Score
• Total Dose of Butorphanol

Interventions

Type	Name	Description
DRUG	Butorphanol	intravenous loading dose of 15ug/kg butorphanol,and followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion until the Ramsay sedation score reached 4 points
OTHER	physiological saline	intravenous infusion of the same volume of physiological saline

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-12-20
• Completion: 2018-12-31
• First posted: 2019-01-18
• Last updated: 2019-01-18

Locations

1 site across 1 country: China