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	78 years old

2.2.Weight

Weight	70 kg

Weight

70 kg

2.3.Height

Height	1.75 m

Height

1.75 m

2.4.BMI

BMI	22.86 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	158 mmHg
Systolic pressure T2	167 mmHg
Systolic pressure T3	177 mmHg
Systolic pressure T4	166 mmHg
Systolic pressure T5	166 mmHg
Systolic pressure T6	165 mmHg
Systolic pressure T7	167 mmHg
Systolic pressure T8	168 mmHg
Systolic pressure T9	167 mmHg
Systolic pressure T10	178 mmHg
Systolic pressure T11	158 mmHg
Systolic pressure T12	163 mmHg
Systolic pressure T13	155 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	75 mmHg
Diastolic pressure T2	67 mmHg
Diastolic pressure T3	82 mmHg
Diastolic pressure T4	77 mmHg
Diastolic pressure T5	78 mmHg
Diastolic pressure T6	77 mmHg
Diastolic pressure T7	95 mmHg
Diastolic pressure T8	81 mmHg
Diastolic pressure T9	84 mmHg
Diastolic pressure T10	86 mmHg
Diastolic pressure T11	76 mmHg
Diastolic pressure T12	79 mmHg
Diastolic pressure T13	78 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	102 mmHg
Mean arterial pressure T2	100 mmHg
Mean arterial pressure T3	103 mmHg
Mean arterial pressure T4	106 mmHg
Mean arterial pressure T5	99 mmHg
Mean arterial pressure T6	106 mmHg
Mean arterial pressure T7	115 mmHg
Mean arterial pressure T8	110 mmHg
Mean arterial pressure T9	102 mmHg
Mean arterial pressure T10	116 mmHg
Mean arterial pressure T11	103 mmHg
Mean arterial pressure T12	111 mmHg
Mean arterial pressure T13	103 mmHg

3.4.Heart rate

Heart rate T1	79 times/min
Heart rate T2	71 times/min
Heart rate T3	69 times/min
Heart rate T4	66 times/min
Heart rate T5	65 times/min
Heart rate T6	68 times/min
Heart rate T7	67 times/min
Heart rate T8	64 times/min
Heart rate T9	65 mmHg
Heart rate T10	59 times/min
Heart rate T11	67 times/min
Heart rate T12	64 times/min
Heart rate T13	69 times/min

3.5.Respiratory rate

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

3.6.Oxygen saturation

Oxygen saturation T1	93 %
Oxygen saturation T2	97 %
Oxygen saturation T3	95 %
Oxygen saturation T4	95 %
Oxygen saturation T5	95 %
Oxygen saturation T6	93 %
Oxygen saturation T7	93 %
Oxygen saturation T8	95 %
Oxygen saturation T9	94 %
Oxygen saturation T10	97 %
Oxygen saturation T11	98 %
Oxygen saturation T12	99 %
Oxygen saturation T13	94 %

3.7.BIS

BIS T1	95
BIS T2	98
BIS T3	96
BIS T4	95
BIS T5	93
BIS T6	85
BIS T7	89
BIS T8	94
BIS T9	97
BIS T10	90
BIS T11	96
BIS T12	96
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	108 min

Operation duration

108 min

4.7.Time-on

Time-on	08:50

Time-on

08:50

4.8.End time

End time	10:38

End time

10:38

4.9.Departure time

Departure time	10:44

Departure time

10:44

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	21

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	29

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