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	82 years old

2.2.Weight

Weight	55 kg

Weight

55 kg

2.3.Height

Height	1.62 m

Height

1.62 m

2.4.BMI

BMI	20.96 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	166 mmHg
Systolic pressure T2	147 mmHg
Systolic pressure T3	164 mmHg
Systolic pressure T4	157 mmHg
Systolic pressure T5	161 mmHg
Systolic pressure T6	149 mmHg
Systolic pressure T7	154 mmHg
Systolic pressure T8	152 mmHg
Systolic pressure T9	153 mmHg
Systolic pressure T10	165 mmHg
Systolic pressure T11	159 mmHg
Systolic pressure T12	167 mmHg
Systolic pressure T13	157 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	94 mmHg
Diastolic pressure T2	88 mmHg
Diastolic pressure T3	94 mmHg
Diastolic pressure T4	94 mmHg
Diastolic pressure T5	96 mmHg
Diastolic pressure T6	90 mmHg
Diastolic pressure T7	96 mmHg
Diastolic pressure T8	91 mmHg
Diastolic pressure T9	90 mmHg
Diastolic pressure T10	93 mmHg
Diastolic pressure T11	92 mmHg
Diastolic pressure T12	94 mmHg
Diastolic pressure T13	91 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	120 mmHg
Mean arterial pressure T2	117 mmHg
Mean arterial pressure T3	127 mmHg
Mean arterial pressure T4	120 mmHg
Mean arterial pressure T5	127 mmHg
Mean arterial pressure T6	123 mmHg
Mean arterial pressure T7	128 mmHg
Mean arterial pressure T8	126 mmHg
Mean arterial pressure T9	123 mmHg
Mean arterial pressure T10	123 mmHg
Mean arterial pressure T11	118 mmHg
Mean arterial pressure T12	118 mmHg
Mean arterial pressure T13	113 mmHg

3.4.Heart rate

Heart rate T1	74 times/min
Heart rate T2	80 times/min
Heart rate T3	81 times/min
Heart rate T4	78 times/min
Heart rate T5	74 times/min
Heart rate T6	72 times/min
Heart rate T7	74 times/min
Heart rate T8	70 times/min
Heart rate T9	68 mmHg
Heart rate T10	69 times/min
Heart rate T11	68 times/min
Heart rate T12	69 times/min
Heart rate T13	70 times/min

3.5.Respiratory rate

Respiratory rate T1	8 times/min
Respiratory rate T2	13 times/min
Respiratory rate T3	12 times/min
Respiratory rate T4	12 times/min
Respiratory rate T5	10 times/min
Respiratory rate T6	9 times/min
Respiratory rate T7	12 times/min
Respiratory rate T8	19 times/min
Respiratory rate T9	16 times/min
Respiratory rate T10	15 times/min
Respiratory rate T11	8 times/min
Respiratory rate T12	9 times/min
Respiratory rate T13	9 times/min

3.6.Oxygen saturation

Oxygen saturation T1	100 %
Oxygen saturation T2	98 %
Oxygen saturation T3	99 %
Oxygen saturation T4	98 %
Oxygen saturation T5	98 %
Oxygen saturation T6	99 %
Oxygen saturation T7	98 %
Oxygen saturation T8	98 %
Oxygen saturation T9	98 %
Oxygen saturation T10	9 %
Oxygen saturation T11	897 %
Oxygen saturation T12	97 %
Oxygen saturation T13	98 %

3.7.BIS

BIS T1	85
BIS T2	94
BIS T3	90
BIS T4	95
BIS T5	96
BIS T6	85
BIS T7	90
BIS T8	90
BIS T9	85
BIS T10	88
BIS T11	87
BIS T12	88
BIS T13	84

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	63 min

Operation duration

63 min

4.7.Time-on

Time-on	12:30

Time-on

12:30

4.8.End time

End time	13:37

End time

13:37

4.9.Departure time

Departure time	13:43

Departure time

13:43

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	20

Postoperative day STAI-S

5.2.

5.5.2.5.2.1、1 day preoperative MMSE

1 day preoperative MMSE	28

1 day preoperative MMSE

5.5.2.5.2.2、Postoperative day MMSE

Poseoperative day MMSE	28

Poseoperative day MMSE

5.5.2.5.2.3、Postoperative 1-day MMSE

Postoperative 1-day MMSE	28

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