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	77 years old

2.2.Weight

Weight	59 kg

Weight

59 kg

2.3.Height

Height	1.60 m

Height

1.60 m

2.4.BMI

BMI	23.05 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	Diabetes

Underlying disease

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	143 mmHg
Systolic pressure T2	127 mmHg
Systolic pressure T3	140 mmHg
Systolic pressure T4	147 mmHg
Systolic pressure T5	153 mmHg
Systolic pressure T6	142 mmHg
Systolic pressure T7	144 mmHg
Systolic pressure T8	135 mmHg
Systolic pressure T9	138 mmHg
Systolic pressure T10	139 mmHg
Systolic pressure T11	142 mmHg
Systolic pressure T12	140 mmHg
Systolic pressure T13	133 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	79 mmHg
Diastolic pressure T2	60 mmHg
Diastolic pressure T3	66 mmHg
Diastolic pressure T4	72 mmHg
Diastolic pressure T5	77 mmHg
Diastolic pressure T6	77 mmHg
Diastolic pressure T7	71 mmHg
Diastolic pressure T8	74 mmHg
Diastolic pressure T9	74 mmHg
Diastolic pressure T10	74 mmHg
Diastolic pressure T11	73 mmHg
Diastolic pressure T12	80 mmHg
Diastolic pressure T13	74 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	104 mmHg
Mean arterial pressure T2	92 mmHg
Mean arterial pressure T3	83 mmHg
Mean arterial pressure T4	105 mmHg
Mean arterial pressure T5	102 mmHg
Mean arterial pressure T6	111 mmHg
Mean arterial pressure T7	111 mmHg
Mean arterial pressure T8	104 mmHg
Mean arterial pressure T9	98 mmHg
Mean arterial pressure T10	98 mmHg
Mean arterial pressure T11	96 mmHg
Mean arterial pressure T12	101 mmHg
Mean arterial pressure T13	93 mmHg

3.4.Heart rate

Heart rate T1	80 times/min
Heart rate T2	83 times/min
Heart rate T3	79 times/min
Heart rate T4	74 times/min
Heart rate T5	75 times/min
Heart rate T6	75 times/min
Heart rate T7	74 times/min
Heart rate T8	72 times/min
Heart rate T9	75 mmHg
Heart rate T10	73 times/min
Heart rate T11	71 times/min
Heart rate T12	78 times/min
Heart rate T13	72 times/min

3.5.Respiratory rate

Respiratory rate T1	15 times/min
Respiratory rate T2	15 times/min
Respiratory rate T3	16 times/min
Respiratory rate T4	12 times/min
Respiratory rate T5	13 times/min
Respiratory rate T6	12 times/min
Respiratory rate T7	18 times/min
Respiratory rate T8	13 times/min
Respiratory rate T9	18 times/min
Respiratory rate T10	14 times/min
Respiratory rate T11	21 times/min
Respiratory rate T12	14 times/min
Respiratory rate T13	13 times/min

3.6.Oxygen saturation

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

3.7.BIS

BIS T1	98
BIS T2	98
BIS T3	98
BIS T4	93
BIS T5	96
BIS T6	97
BIS T7	96
BIS T8	93
BIS T9	94
BIS T10	92
BIS T11	91
BIS T12	97
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	L3-4

Puncture space

L3-4

4.2.Dosage of ropivacaine

Dosage of ropivacaine	20 mg

Dosage of ropivacaine

20 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	66 min

Operation duration

66 min

4.7.Time-on

Time-on	10:16

Time-on

10:16

4.8.End time

End time	11:22

End time

11:22

4.9.Departure time

Departure time	11:28

Departure time

11:28

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	20

1 day preoperative STAI-S

5.5.1.5.1.2、Postoperative day STAI-S

Postoperative day STAI-S	20

Postoperative day STAI-S

5.2.

5.5.2.5.2.1、1 day preoperative MMSE

1 day preoperative MMSE	26

1 day preoperative MMSE

5.5.2.5.2.2、Postoperative day MMSE

Poseoperative day MMSE	29

Poseoperative day MMSE

5.5.2.5.2.3、Postoperative 1-day MMSE

Postoperative 1-day MMSE	30

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