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
Change the anesthesia method to general anesthesia for patients	NO
Intraoperative use of other sedative drugs	NO
Patients transferred to ICU after surgery	NO

2.Baseline

Age
Weight
Height
BMI
Degree of education
ASA
Underlying disease

2.1.Age

Age	66 years old

2.2.Weight

Weight	70 kg

Weight

70 kg

2.3.Height

Height	1.78 m

Height

1.78 m

2.4.BMI

BMI	22.09 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	165 mmHg
Systolic pressure T2	166 mmHg
Systolic pressure T3	158 mmHg
Systolic pressure T4	159 mmHg
Systolic pressure T5	151 mmHg
Systolic pressure T6	150 mmHg
Systolic pressure T7	153 mmHg
Systolic pressure T8	166 mmHg
Systolic pressure T9	173 mmHg
Systolic pressure T10	170 mmHg
Systolic pressure T11	163 mmHg
Systolic pressure T12	177 mmHg
Systolic pressure T13	159 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	80 mmHg
Diastolic pressure T2	79 mmHg
Diastolic pressure T3	79 mmHg
Diastolic pressure T4	93 mmHg
Diastolic pressure T5	92 mmHg
Diastolic pressure T6	90 mmHg
Diastolic pressure T7	92 mmHg
Diastolic pressure T8	91 mmHg
Diastolic pressure T9	89 mmHg
Diastolic pressure T10	91 mmHg
Diastolic pressure T11	99 mmHg
Diastolic pressure T12	90 mmHg
Diastolic pressure T13	92 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	120 mmHg
Mean arterial pressure T2	116 mmHg
Mean arterial pressure T3	111 mmHg
Mean arterial pressure T4	115 mmHg
Mean arterial pressure T5	113 mmHg
Mean arterial pressure T6	110 mmHg
Mean arterial pressure T7	109 mmHg
Mean arterial pressure T8	116 mmHg
Mean arterial pressure T9	104 mmHg
Mean arterial pressure T10	104 mmHg
Mean arterial pressure T11	109 mmHg
Mean arterial pressure T12	104 mmHg
Mean arterial pressure T13	104 mmHg

3.4.Heart rate

Heart rate T1	59 times/min
Heart rate T2	55 times/min
Heart rate T3	61 times/min
Heart rate T4	54 times/min
Heart rate T5	54 times/min
Heart rate T6	51 times/min
Heart rate T7	53 times/min
Heart rate T8	50 times/min
Heart rate T9	48 mmHg
Heart rate T10	48 times/min
Heart rate T11	50 times/min
Heart rate T12	55 times/min
Heart rate T13	58 times/min

3.5.Respiratory rate

Respiratory rate T1	18 times/min
Respiratory rate T2	18 times/min
Respiratory rate T3	19 times/min
Respiratory rate T4	17 times/min
Respiratory rate T5	13 times/min
Respiratory rate T6	12 times/min
Respiratory rate T7	14 times/min
Respiratory rate T8	15 times/min
Respiratory rate T9	14 times/min
Respiratory rate T10	13 times/min
Respiratory rate T11	18 times/min
Respiratory rate T12	16 times/min
Respiratory rate T13	16 times/min

3.6.Oxygen saturation

Oxygen saturation T1	96 %
Oxygen saturation T2	96 %
Oxygen saturation T3	95 %
Oxygen saturation T4	96 %
Oxygen saturation T5	96 %
Oxygen saturation T6	95 %
Oxygen saturation T7	96 %
Oxygen saturation T8	97 %
Oxygen saturation T9	96 %
Oxygen saturation T10	97 %
Oxygen saturation T11	96 %
Oxygen saturation T12	96 %
Oxygen saturation T13	98 %

3.7.BIS

BIS T1	96
BIS T2	98
BIS T3	97
BIS T4	97
BIS T5	92
BIS T6	91
BIS T7	88
BIS T8	75
BIS T9	78
BIS T10	83
BIS T11	84
BIS T12	95
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	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	54 min

Operation duration

54 min

4.7.Time-on

Time-on	08:42

Time-on

08:42

4.8.End time

End time	09:36

End time

09:36

4.9.Departure time

Departure time	09:42

Departure time

09:42

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	YES

Bradycardia

YES

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	30

1 day preoperative MMSE

5.5.2.5.2.2、Postoperative day MMSE

Poseoperative day MMSE	30

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