临床试验公共管理平台 Clinical Trial Management Public Platform

Screening
Baseline
Intraoperative indicators
Intraoperative secondary data
Follow-up

1.Screening

Inclusion Criteria
Exclusion Criteria
Detachment Criteria

1.1.Inclusion Criteria

Patients planning to undergo elective intraspinal anesthesia for prostate resection surgery	YES
Age 60 and above (including 60 years old)	YES
Body mass index (BMI) 18.5-30kg/m^2	YES
ASA grade I-III	YES
	YES

1.2.Exclusion Criteria

Individuals with hearing and visual impairments	NO
BMI ≥ 30	NO
Individuals with contraindications for spinal anesthesia	NO
Severe hypertension (controlled with medication, still in stage III or above hypertension), heart failure (NYHA > II)	NO
Severe bradycardia (requiring pacemaker, <60bpm)	NO
Individuals with neurological or muscular system diseases, mental illness	NO
History of sedative, antidepressant medication use, alcoholism, and drug abuse	NO
History of severe cerebrovascular disease or complication after craniocerebral trauma (e.g., emotional disorders, language disorders)	NO
Individuals with dexmedetomidine use contraindications	NO
Individuals who are unwilling or unable to communicate	NO

1.3.Detachment Criteria

loss to follow-up	NO
Subject withdraws informed consent form	NO
Intraoperative use of other sedative drugs	NO
Change the anesthesia method to general anesthesia for patients	NO
Patients transferred to ICU after surgery	NO

2.Baseline

Age
Weight
Height
BMI
Degree of education
ASA
Underlying disease

2.1.Age

Age	85 years old

2.2.Weight

Weight	70 kg

Weight

70 kg

2.3.Height

Height	1.65 m

Height

1.65 m

2.4.BMI

BMI	25.71 kg/m2

2.5.Degree of education

Degree of education	Middle school

Degree of education

Middle school

2.6.ASA

ASA	Ⅱ

ASA

Ⅱ

2.7.Underlying disease

Underlying disease	Hypertention / Diabetes

Underlying disease

Hypertention

Diabetes

3.Intraoperative indicators

Systolic pressure
Diastolic pressure
Mean arterial pressure
Heart rate
Respiratory rate
Oxygen saturation
BIS

3.1.Systolic pressure

Systolic pressure T1	150 mmHg
Systolic pressure T2	121 mmHg
Systolic pressure T3	110 mmHg
Systolic pressure T4	117 mmHg
Systolic pressure T5	118 mmHg
Systolic pressure T6	113 mmHg
Systolic pressure T7	114 mmHg
Systolic pressure T8	122 mmHg
Systolic pressure T9	114 mmHg
Systolic pressure T10	123 mmHg
Systolic pressure T11	120 mmHg
Systolic pressure T12	135 mmHg
Systolic pressure T13	141 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	91 mmHg
Diastolic pressure T2	74 mmHg
Diastolic pressure T3	67 mmHg
Diastolic pressure T4	76 mmHg
Diastolic pressure T5	76 mmHg
Diastolic pressure T6	75 mmHg
Diastolic pressure T7	69 mmHg
Diastolic pressure T8	78 mmHg
Diastolic pressure T9	73 mmHg
Diastolic pressure T10	72 mmHg
Diastolic pressure T11	78 mmHg
Diastolic pressure T12	82 mmHg
Diastolic pressure T13	80 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	110 mmHg
Mean arterial pressure T2	89 mmHg
Mean arterial pressure T3	81 mmHg
Mean arterial pressure T4	84 mmHg
Mean arterial pressure T5	91 mmHg
Mean arterial pressure T6	82 mmHg
Mean arterial pressure T7	80 mmHg
Mean arterial pressure T8	85 mmHg
Mean arterial pressure T9	82 mmHg
Mean arterial pressure T10	82 mmHg
Mean arterial pressure T11	86 mmHg
Mean arterial pressure T12	101 mmHg
Mean arterial pressure T13	100 mmHg

3.4.Heart rate

Heart rate T1	90 times/min
Heart rate T2	80 times/min
Heart rate T3	93 times/min
Heart rate T4	83 times/min
Heart rate T5	981 times/min
Heart rate T6	78 times/min
Heart rate T7	78 times/min
Heart rate T8	76 times/min
Heart rate T9	74 mmHg
Heart rate T10	76 times/min
Heart rate T11	74 times/min
Heart rate T12	77 times/min
Heart rate T13	81 times/min

3.5.Respiratory rate

Respiratory rate T1	17 times/min
Respiratory rate T2	16 times/min
Respiratory rate T3	17 times/min
Respiratory rate T4	12 times/min
Respiratory rate T5	15 times/min
Respiratory rate T6	17 times/min
Respiratory rate T7	16 times/min
Respiratory rate T8	18 times/min
Respiratory rate T9	14 times/min
Respiratory rate T10	16 times/min
Respiratory rate T11	18 times/min
Respiratory rate T12	21 times/min
Respiratory rate T13	18 times/min

3.6.Oxygen saturation

Oxygen saturation T1	100 %
Oxygen saturation T2	99 %
Oxygen saturation T3	100 %
Oxygen saturation T4	100 %
Oxygen saturation T5	99 %
Oxygen saturation T6	99 %
Oxygen saturation T7	99 %
Oxygen saturation T8	99 %
Oxygen saturation T9	97 %
Oxygen saturation T10	98 %
Oxygen saturation T11	98 %
Oxygen saturation T12	98 %
Oxygen saturation T13	98 %

3.7.BIS

BIS T1	98
BIS T2	96
BIS T3	98
BIS T4	96
BIS T5	97
BIS T6	91
BIS T7	95
BIS T8	93
BIS T9	95
BIS T10	95
BIS T11	85
BIS T12	98
BIS T13	98

4.Intraoperative secondary data

Puncture space
Dosage of ropivacaine
Sensory blockade plane
Improved Bromage score
Operation duration
Time-on
End time
Departure time
Total dosage of dexmedetomidine
Satisfaction
Special circumstances during surgery

4.1.Puncture space

Puncture space	L2-3

Puncture space

L2-3

4.2.Dosage of ropivacaine

Dosage of ropivacaine	18 mg

Dosage of ropivacaine

18 mg

4.3.Sensory blockade plane

Sensory blockade plane	T10

Sensory blockade plane

T10

4.4.Improved Bromage score

Improved Bromage score	3

Improved Bromage score

4.5.

A-VAS	0

A-VAS

4.6.Operation duration

Operation duration	205 min

Operation duration

205 min

4.7.Time-on

Time-on	14:05

Time-on

14:05

4.8.End time

End time	17:30

End time

17:30

4.9.Departure time

Departure time	17:43

Departure time

17:43

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	0 mg

Total dosage of dexmedetomidine

0 mg

4.11.Satisfaction

4.4.11.4.11.1、Operator satisfaction

Operator satisfaction	5

Operator satisfaction

4.4.11.4.11.2、Patient satisfaction

Patient satisfaction	5

Patient satisfaction

4.12.Special circumstances during surgery

4.4.12.4.12.1、Physical movement

Physical movement	NO

Physical movement

4.4.12.4.12.2、Hypoxemia

Hypoxemia	NO

Hypoxemia

4.4.12.4.12.3、Bradycardia

Bradycardia	NO

Bradycardia

5.Follow-up

Postoperative adverse reactions

5.1.

5.5.1.5.1.1、1 day preoperative STAI-S

1 day preoperative STAI-S	22

1 day preoperative STAI-S

5.5.1.5.1.2、Postoperative day STAI-S

Postoperative day STAI-S	21

Postoperative day STAI-S

5.2.

5.5.2.5.2.1、1 day preoperative MMSE

1 day preoperative MMSE	27

1 day preoperative MMSE

5.5.2.5.2.2、Postoperative day MMSE

Poseoperative day MMSE	27

Poseoperative day MMSE

5.5.2.5.2.3、Postoperative 1-day MMSE

Postoperative 1-day MMSE	29

Postoperative 1-day MMSE

5.3.Postoperative adverse reactions

5.5.3.5.3.1、Nausea

Nausea	NO

Nausea

5.5.3.5.3.2、Vomit

Vomit	NO

Vomit

5.5.3.5.3.3、Dizzy

Dizzy	NO

Dizzy

5.5.3.5.3.4、Headache

Headache

5.5.3.5.3.5、Respiratory suppression

Respiratory suppression