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

• ClinicalTrials.gov Identifier: NCT03810391
• Recruitment Status: Completed
• First Posted: January 18, 2019
• Last Update Posted: January 18, 2019
• Sponsor: Shengjing Hospital
• Information provided by (Responsible Party): Yanchao Yang, Shengjing Hospital

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Preoperative Anxiety Score; Total Dose of Butorphanol	Drug: Butorphanol; Other: physiological saline	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 126 participants
• 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
• Official Title: 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
• Actual Study Start Date: December 1, 2017
• Actual Primary Completion Date: December 20, 2018
• Actual Study Completion Date: December 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: preoperative anxiety and butorphanol; preoperative anxiety scores of patients in Group A were >11 and 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	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 Name: butorphanol tartrate injection
Placebo Comparator: preoperative anxiety and saline; preoperative anxiety scores of patients in Group B were >11 and received an infusion of the same volume of physiological saline	Other: physiological saline; intravenous infusion of the same volume of physiological saline
Experimental: non-preoperative anxiety and butorphanol; preoperative anxiety scores of patients in Group C were ≤ 11 and 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	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 Name: butorphanol tartrate injection
Placebo Comparator: non-preoperative anxiety and saline; preoperative anxiety scores of patients in Group D were ≤11 and received an infusion of the same volume of physiological saline	Other: physiological saline; intravenous infusion of the same volume of physiological saline

Outcome Measures

Primary Outcome Measures :

1. preoperative anxiety score (Amsterdam preoperative anxiety and information scale, APAIS) [ Time Frame: one day before the surgery ]
   evaluate the preoperative anxiety score one day before the surgery, the scale ranges from 0-33. And we define a score of 11 as a cut-off point, the higher the score the more serious the preoperative anxiety is
2. Ramsay sedation score (Ramsay sedation scale, RSS) [ Time Frame: during the surgery ]
   evaluate the Ramsay sedation score 10 min after getting into the operation room and 5, 10, 15, 30min after infusion. The Ramsay sedation scale 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. A sedative state with RSS 4 was considered as an adequate level of sedation
3. 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 scale 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. A sedative state with RSS 4 was considered as an adequate level of sedation

Secondary Outcome Measures :

1. vital signs [ Time Frame: during the surgery ]
   Record Mean Arterial Pressure(MAP)10 min after getting into the operation room and 5, 10, 15, 30min after infusion
2. The incidence of nausea/ vomiting, dizzy, bradycardia and hypotension [ Time Frame: in the first day after the surgery ]
   Investigate the incidence of nausea/ vomiting, dizzy, bradycardia and hypotension in the first day after the surgery
3. post-operative visual analgesia scale scores (VAS) [ Time Frame: within 24 hours after the surgery ]
   investigate the VAS every hour till 6 hours and then every 2 hours till 24 hours. The VAS ranges from 1-10. 0 means painless; 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain
4. Vital signs [ Time Frame: during the surgery ]
   Record Spo2 10 min after getting into the operation room and 5, 10, 15, 30min after infusion
5. Vital signs [ Time Frame: during the surgery ]
   Record Heart Rate(HR) 10 min after getting into the operation room and 5, 10, 15, 30min after infusion

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ
• 18-75 years
• Scheduled for elective low limb orthopaedic procedures under spinal anesthesia

Exclusion Criteria:

• central system disease
• cardiovascular disease
• autonomic nervous system disease
• long term use of analgesic, sedative, and anti-anxiety drugs
• psychosis
• a patient with a language communication disorder not willing to cooperate with the experimenter

Contacts and Locations

Locations

China, Liao Ning

shengjing hospital of China medical university

Shenyang, Liao Ning, China, 110004

Sponsors and Collaborators

Shengjing Hospital

Investigators

• Study Director: Junchao Zhu, professor; Shengjing Hospital

More Information

• Responsible Party: Yanchao Yang, Principal Investigator, Shengjing Hospital
• ClinicalTrials.gov Identifier: NCT03810391
• Other Study ID Numbers: Effect of butorphanol
• First Posted: January 18, 2019
• Last Update Posted: January 18, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yanchao Yang, Shengjing Hospital:

Butorphanol; preoperative anxiety; sedation; recommend dose

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders; Butorphanol; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antitussive Agents; Respiratory System Agents; Narcotic Antagonists