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	60 kg

Weight

60 kg

2.3.Height

Height	1.60 m

Height

1.60 m

2.4.BMI

BMI	23.44 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	167 mmHg
Systolic pressure T2	142 mmHg
Systolic pressure T3	141 mmHg
Systolic pressure T4	171 mmHg
Systolic pressure T5	147 mmHg
Systolic pressure T6	153 mmHg
Systolic pressure T7	152 mmHg
Systolic pressure T8	134 mmHg
Systolic pressure T9	142 mmHg
Systolic pressure T10	144 mmHg
Systolic pressure T11	138 mmHg
Systolic pressure T12	140 mmHg
Systolic pressure T13	179 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	77 mmHg
Diastolic pressure T2	63 mmHg
Diastolic pressure T3	76 mmHg
Diastolic pressure T4	90 mmHg
Diastolic pressure T5	90 mmHg
Diastolic pressure T6	78 mmHg
Diastolic pressure T7	77 mmHg
Diastolic pressure T8	70 mmHg
Diastolic pressure T9	74 mmHg
Diastolic pressure T10	77 mmHg
Diastolic pressure T11	72 mmHg
Diastolic pressure T12	70 mmHg
Diastolic pressure T13	89 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	107 mmHg
Mean arterial pressure T2	89 mmHg
Mean arterial pressure T3	97 mmHg
Mean arterial pressure T4	117 mmHg
Mean arterial pressure T5	109 mmHg
Mean arterial pressure T6	95 mmHg
Mean arterial pressure T7	102 mmHg
Mean arterial pressure T8	107 mmHg
Mean arterial pressure T9	82 mmHg
Mean arterial pressure T10	99 mmHg
Mean arterial pressure T11	103 mmHg
Mean arterial pressure T12	93 mmHg
Mean arterial pressure T13	103 mmHg

3.4.Heart rate

Heart rate T1	91 times/min
Heart rate T2	79 times/min
Heart rate T3	93 times/min
Heart rate T4	76 times/min
Heart rate T5	73 times/min
Heart rate T6	59 times/min
Heart rate T7	56 times/min
Heart rate T8	56 times/min
Heart rate T9	65 mmHg
Heart rate T10	71 times/min
Heart rate T11	68 times/min
Heart rate T12	69 times/min
Heart rate T13	78 times/min

3.5.Respiratory rate

Respiratory rate T1	20 times/min
Respiratory rate T2	14 times/min
Respiratory rate T3	21 times/min
Respiratory rate T4	14 times/min
Respiratory rate T5	14 times/min
Respiratory rate T6	15 times/min
Respiratory rate T7	19 times/min
Respiratory rate T8	14 times/min
Respiratory rate T9	14 times/min
Respiratory rate T10	15 times/min
Respiratory rate T11	15 times/min
Respiratory rate T12	16 times/min
Respiratory rate T13	12 times/min

3.6.Oxygen saturation

Oxygen saturation T1	100 %
Oxygen saturation T2	99 %
Oxygen saturation T3	99 %
Oxygen saturation T4	99 %
Oxygen saturation T5	99 %
Oxygen saturation T6	95 %
Oxygen saturation T7	98 %
Oxygen saturation T8	97 %
Oxygen saturation T9	96 %
Oxygen saturation T10	99 %
Oxygen saturation T11	96 %
Oxygen saturation T12	99 %
Oxygen saturation T13	100 %

3.7.BIS

BIS T1	97
BIS T2	94
BIS T3	98
BIS T4	88
BIS T5	92
BIS T6	82
BIS T7	56
BIS T8	55
BIS T9	56
BIS T10	58
BIS T11	92
BIS T12	89
BIS T13	95

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	51 min

Operation duration

51 min

4.7.Time-on

Time-on	10:15

Time-on

10:15

4.8.End time

End time	11:06

End time

11:06

4.9.Departure time

Departure time	11:12

Departure time

11:12

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	34.6 mg

Total dosage of dexmedetomidine

34.6 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	YES

Physical movement

YES

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	23

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	22

1 day preoperative MMSE

5.5.2.5.2.2、Postoperative day MMSE

Poseoperative day MMSE	24

Poseoperative day MMSE

5.5.2.5.2.3、Postoperative 1-day MMSE

Postoperative 1-day MMSE	25

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