Using Preoperative Anxiety Score to Determine the Total Dose of Butorphanol for Sedation
Condition: Preoperative Anxiety Score; Total Dose of Butorphanol
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Butorphanol; physiological saline
Intervention type(s): Drug; Other
Intervention description(s): 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; intravenous infusion of the same volume of physiological saline
Other intervention name(s): butorphanol tartrate injection
Intervention MeSH terms: Butorphanol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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 mins before starting the surgery, then followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion when the Ramsay sedation score (RSS) reached 4 , Group B and Group D received an infusion of the same volume of physiological saline
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Butorphanol; preoperative anxiety; sedation; recommend dose