Using Pre-operative Anxiety Score to Determine the Precise Dose of Butorphanol in Patients Undergoing Orthopedic Procedures: A Double-blinded Randomized Trial
Overview
- Phase
- Phase 2
- Intervention
- Butorphanol
- Conditions
- Preoperative Anxiety
- Sponsor
- Shengjing Hospital
- Enrollment
- 155
- Locations
- 1
- Primary Endpoint
- Ramsay Sedation score
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Pre-operative anxiety usually lead to increased anesthetics during the surgery. The precise sedative requirement which can keep adequate sedative state and avoid adverse effects caused by excessive drugs still needs further study. Therefore, our purpose was to confirm the sedative effect of butorphanol and to explore the relationship between pre-operative anxiety and intra-operative butorphanol requirement to evaluate the precise sedative requirement which can keep adequate sedation for patients by pre-operative anxiety score.
Detailed Description
A total of 142 patients (aged 18-75 years) who were scheduled for elective low limb orthopedic procedures under spinal anesthesia were included in this study. Patients were divided into two groups based on pre-operative anxiety score evaluated by the Amsterdam pre-operative anxiety and information scale before the surgery. And intramuscular midazolam 0.05mg/kg as a premedication in preoperative room was given to patients before shifting into operation room. Patients in each group were randomly divided into butorphanol group and 0.9% saline group. The sedation score, the duration of reaching adequate sedation state and postoperative recovery were recorded.
Investigators
Yanchao Yang
Principal Investigator
Shengjing Hospital
Eligibility Criteria
Inclusion Criteria
- •age 18-75 years
- •surgical operation of lower extremities in orthopedics
- •no contraindication of epidural anesthesia
Exclusion Criteria
- •with central system disease
- •with cardiovascular disease
- •with autonomic nervous system disease
- •long term use of analgesic drugs ,sedative drugs,and anti-anxiety drugs
- •language barrier
- •unwilling to cooperate with the experimenter
Arms & Interventions
High anxiety butorphanol group
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in high anxiety butorphanol group were \>10，and 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
Intervention: Butorphanol
High anxiety 0.9% saline group
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in high anxiety 0.9% saline group were \>10, and received an infusion of the same volume of 0.9% saline
Intervention: Physiological saline
Low anxiety butorphanol group
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in low anxiety butorphanol group were ≤10,and 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
Intervention: Butorphanol
Low anxiety 0.9% saline group
preoperative anxiety score of Amsterdam pre-operative anxiety and information scale(APAIS) in low anxiety 0.9% saline group were ≤10, and received an infusion of the same volume of 0.9% saline
Intervention: Physiological saline
Outcomes
Primary Outcomes
Ramsay Sedation score
Time Frame: during the surgery
evaluate the Ramsay sedation score 10min after getting into the operation room and 5,10,15,30min after infusion.The Ramsay Sedation score ranges from 1-6. 1, anxious and agitated or restless or both; 2, cooperative, orientated, and tranquil; 3, responds to commands only; 4, brisk response to a light glabellar tap or auditory stimulus; 5, sluggish response to a light glabellar tap or auditory stimulus; and 6, no response to a light glabellar tap or auditory stimulus
vital signs
Time Frame: during the surgery
Record Mean Arterial Pressure(MAP)10min after getting into the operation room and 5,10,15,30min after infusion
preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS)".
Time Frame: before the surgery
evaluate the preoperative anxiety score before the surgery, APAIS contains 6 items rated on a five-point Likert scale, which represents two scales: anxiety (items 1, 2, 4, and 5) and need for information (items 3 and 6) Accordingly, the maximal score of the entire APAIS (APAIS-T) is 30 and the one expressing the patient's need for information (APAIS-I) is 10. The maximal score of the two items concerning anxiety about anesthesia (APAIS-A-An) and surgery (APAIS-A-Su) is also 10 each, resulting in a maximal score of 20 for total preoperative anxiety (APAIS-A-T). And APAIS-A-T \> 10 was used as a cut-off to define patients with high anxiety, the higher the score, the more serious the pre-operative anxiety is
The time when Ramsay sedation score reached 4 points
Time Frame: Ramsay sedation score reach 4 points during the surgery
record the time when Ramsay sedation score reached 4 points.The Ramsay Sedation score ranges from 1-6. 1, anxious and agitated or restless or both; 2, cooperative, orientated, and tranquil; 3, responds to commands only; 4, brisk response to a light glabellar tap or auditory stimulus; 5, sluggish response to a light glabellar tap or auditory stimulus; and 6, no response to a light glabellar tap or auditory stimulus
Secondary Outcomes
- vital signs(during the surgery)
- Vital signs(during the surgery)
- postoperative patient satisfaction(first day after the surgery)
- post operative visual analgesia scale scores (VAS)(within 24 hours after the surgery)
- The incidence of nausea/vomiting dizzy bradycardia and hypotension(first day after the surgery)