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	67 years old

2.2.Weight

Weight	67.5 kg

Weight

67.5 kg

2.3.Height

Height	1.68 m

Height

1.68 m

2.4.BMI

BMI	23.92 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	155 mmHg
Systolic pressure T2	151 mmHg
Systolic pressure T3	161 mmHg
Systolic pressure T4	172 mmHg
Systolic pressure T5	178 mmHg
Systolic pressure T6	165 mmHg
Systolic pressure T7	156 mmHg
Systolic pressure T8	153 mmHg
Systolic pressure T9	145 mmHg
Systolic pressure T10	135 mmHg
Systolic pressure T11	141 mmHg
Systolic pressure T12	146 mmHg
Systolic pressure T13	130 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	76 mmHg
Diastolic pressure T2	73 mmHg
Diastolic pressure T3	79 mmHg
Diastolic pressure T4	86 mmHg
Diastolic pressure T5	88 mmHg
Diastolic pressure T6	89 mmHg
Diastolic pressure T7	90 mmHg
Diastolic pressure T8	83 mmHg
Diastolic pressure T9	82 mmHg
Diastolic pressure T10	79 mmHg
Diastolic pressure T11	82 mmHg
Diastolic pressure T12	85 mmHg
Diastolic pressure T13	74 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	113 mmHg
Mean arterial pressure T2	118 mmHg
Mean arterial pressure T3	122 mmHg
Mean arterial pressure T4	147 mmHg
Mean arterial pressure T5	155 mmHg
Mean arterial pressure T6	136 mmHg
Mean arterial pressure T7	132 mmHg
Mean arterial pressure T8	126 mmHg
Mean arterial pressure T9	116 mmHg
Mean arterial pressure T10	109 mmHg
Mean arterial pressure T11	117 mmHg
Mean arterial pressure T12	105 mmHg
Mean arterial pressure T13	98 mmHg

3.4.Heart rate

Heart rate T1	68 times/min
Heart rate T2	65 times/min
Heart rate T3	64 times/min
Heart rate T4	61 times/min
Heart rate T5	58 times/min
Heart rate T6	50 times/min
Heart rate T7	53 times/min
Heart rate T8	53 times/min
Heart rate T9	51 mmHg
Heart rate T10	53 times/min
Heart rate T11	46 times/min
Heart rate T12	51 times/min
Heart rate T13	51 times/min

3.5.Respiratory rate

Respiratory rate T1	19 times/min
Respiratory rate T2	19 times/min
Respiratory rate T3	18 times/min
Respiratory rate T4	18 times/min
Respiratory rate T5	17 times/min
Respiratory rate T6	15 times/min
Respiratory rate T7	20 times/min
Respiratory rate T8	19 times/min
Respiratory rate T9	24 times/min
Respiratory rate T10	25 times/min
Respiratory rate T11	14 times/min
Respiratory rate T12	19 times/min
Respiratory rate T13	12 times/min

3.6.Oxygen saturation

Oxygen saturation T1	97 %
Oxygen saturation T2	98 %
Oxygen saturation T3	99 %
Oxygen saturation T4	100 %
Oxygen saturation T5	100 %
Oxygen saturation T6	100 %
Oxygen saturation T7	96 %
Oxygen saturation T8	98 %
Oxygen saturation T9	98 %
Oxygen saturation T10	98 %
Oxygen saturation T11	98 %
Oxygen saturation T12	98 %
Oxygen saturation T13	97 %

3.7.BIS

BIS T1	98
BIS T2	98
BIS T3	97
BIS T4	98
BIS T5	98
BIS T6	96
BIS T7	86
BIS T8	79
BIS T9	64
BIS T10	67
BIS T11	80
BIS T12	98
BIS T13	96

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	106 min

Operation duration

106 min

4.7.Time-on

Time-on	11:35

Time-on

11:35

4.8.End time

End time	13:21

End time

13:21

4.9.Departure time

Departure time	13:27

Departure time

13:27

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	44.56 mg

Total dosage of dexmedetomidine

44.56 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	25

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	27

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