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	65 years old

2.2.Weight

Weight	57.5 kg

Weight

57.5 kg

2.3.Height

Height	1.68 m

Height

1.68 m

2.4.BMI

BMI	20.37 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	None

Underlying disease

None

3.Intraoperative indicators

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

3.1.Systolic pressure

Systolic pressure T1	154 mmHg
Systolic pressure T2	173 mmHg
Systolic pressure T3	165 mmHg
Systolic pressure T4	147 mmHg
Systolic pressure T5	148 mmHg
Systolic pressure T6	134 mmHg
Systolic pressure T7	136 mmHg
Systolic pressure T8	135 mmHg
Systolic pressure T9	133 mmHg
Systolic pressure T10	122 mmHg
Systolic pressure T11	150 mmHg
Systolic pressure T12	145 mmHg
Systolic pressure T13	150 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	90 mmHg
Diastolic pressure T2	93 mmHg
Diastolic pressure T3	92 mmHg
Diastolic pressure T4	88 mmHg
Diastolic pressure T5	90 mmHg
Diastolic pressure T6	86 mmHg
Diastolic pressure T7	86 mmHg
Diastolic pressure T8	88 mmHg
Diastolic pressure T9	83 mmHg
Diastolic pressure T10	82 mmHg
Diastolic pressure T11	88 mmHg
Diastolic pressure T12	89 mmHg
Diastolic pressure T13	90 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	111 mmHg
Mean arterial pressure T2	119 mmHg
Mean arterial pressure T3	116 mmHg
Mean arterial pressure T4	100 mmHg
Mean arterial pressure T5	102 mmHg
Mean arterial pressure T6	94 mmHg
Mean arterial pressure T7	105 mmHg
Mean arterial pressure T8	97 mmHg
Mean arterial pressure T9	92 mmHg
Mean arterial pressure T10	90 mmHg
Mean arterial pressure T11	108 mmHg
Mean arterial pressure T12	107 mmHg
Mean arterial pressure T13	108 mmHg

3.4.Heart rate

Heart rate T1	67 times/min
Heart rate T2	71 times/min
Heart rate T3	81 times/min
Heart rate T4	71 times/min
Heart rate T5	69 times/min
Heart rate T6	64 times/min
Heart rate T7	60 times/min
Heart rate T8	59 times/min
Heart rate T9	60 mmHg
Heart rate T10	60 times/min
Heart rate T11	60 times/min
Heart rate T12	61 times/min
Heart rate T13	64 times/min

3.5.Respiratory rate

Respiratory rate T1	14 times/min
Respiratory rate T2	14 times/min
Respiratory rate T3	11 times/min
Respiratory rate T4	12 times/min
Respiratory rate T5	11 times/min
Respiratory rate T6	10 times/min
Respiratory rate T7	9 times/min
Respiratory rate T8	9 times/min
Respiratory rate T9	10 times/min
Respiratory rate T10	10 times/min
Respiratory rate T11	13 times/min
Respiratory rate T12	10 times/min
Respiratory rate T13	11 times/min

3.6.Oxygen saturation

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

3.7.BIS

BIS T1	97
BIS T2	98
BIS T3	95
BIS T4	85
BIS T5	78
BIS T6	82
BIS T7	89
BIS T8	76
BIS T9	92
BIS T10	92
BIS T11	97
BIS T12	96
BIS T13	97

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	112 min

Operation duration

112 min

4.7.Time-on

Time-on	08:30

Time-on

08:30

4.8.End time

End time	10:22

End time

10:22

4.9.Departure time

Departure time	10:32

Departure time

10:32

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	30

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