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	73 years old

2.2.Weight

Weight	95 kg

Weight

95 kg

2.3.Height

Height	1.70 m

Height

1.70 m

2.4.BMI

BMI	29.41 kg/m2

2.5.Degree of education

Degree of education	Middle school

Degree of education

Middle school

2.6.ASA

ASA	Ⅲ

ASA

Ⅲ

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	145 mmHg
Systolic pressure T2	155 mmHg
Systolic pressure T3	164 mmHg
Systolic pressure T4	162 mmHg
Systolic pressure T5	140 mmHg
Systolic pressure T6	135 mmHg
Systolic pressure T7	139 mmHg
Systolic pressure T8	129 mmHg
Systolic pressure T9	138 mmHg
Systolic pressure T10	134 mmHg
Systolic pressure T11	123 mmHg
Systolic pressure T12	131 mmHg
Systolic pressure T13	129 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	77 mmHg
Diastolic pressure T2	78 mmHg
Diastolic pressure T3	83 mmHg
Diastolic pressure T4	75 mmHg
Diastolic pressure T5	72 mmHg
Diastolic pressure T6	69 mmHg
Diastolic pressure T7	74 mmHg
Diastolic pressure T8	81 mmHg
Diastolic pressure T9	74 mmHg
Diastolic pressure T10	77 mmHg
Diastolic pressure T11	75 mmHg
Diastolic pressure T12	77 mmHg
Diastolic pressure T13	74 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	97 mmHg
Mean arterial pressure T2	109 mmHg
Mean arterial pressure T3	111 mmHg
Mean arterial pressure T4	104 mmHg
Mean arterial pressure T5	96 mmHg
Mean arterial pressure T6	101 mmHg
Mean arterial pressure T7	93 mmHg
Mean arterial pressure T8	103 mmHg
Mean arterial pressure T9	104 mmHg
Mean arterial pressure T10	96 mmHg
Mean arterial pressure T11	95 mmHg
Mean arterial pressure T12	96 mmHg
Mean arterial pressure T13	87 mmHg

3.4.Heart rate

Heart rate T1	70 times/min
Heart rate T2	75 times/min
Heart rate T3	75 times/min
Heart rate T4	78 times/min
Heart rate T5	63 times/min
Heart rate T6	65 times/min
Heart rate T7	63 times/min
Heart rate T8	62 times/min
Heart rate T9	58 mmHg
Heart rate T10	60 times/min
Heart rate T11	66 times/min
Heart rate T12	65 times/min
Heart rate T13	73 times/min

3.5.Respiratory rate

Respiratory rate T1	14 times/min
Respiratory rate T2	18 times/min
Respiratory rate T3	16 times/min
Respiratory rate T4	16 times/min
Respiratory rate T5	17 times/min
Respiratory rate T6	14 times/min
Respiratory rate T7	15 times/min
Respiratory rate T8	16 times/min
Respiratory rate T9	15 times/min
Respiratory rate T10	20 times/min
Respiratory rate T11	13 times/min
Respiratory rate T12	16 times/min
Respiratory rate T13	18 times/min

3.6.Oxygen saturation

Oxygen saturation T1	91 %
Oxygen saturation T2	94 %
Oxygen saturation T3	96 %
Oxygen saturation T4	99 %
Oxygen saturation T5	98 %
Oxygen saturation T6	99 %
Oxygen saturation T7	998 %
Oxygen saturation T8	89 %
Oxygen saturation T9	97 %
Oxygen saturation T10	97 %
Oxygen saturation T11	97 %
Oxygen saturation T12	97 %
Oxygen saturation T13	94 %

3.7.BIS

BIS T1	97
BIS T2	97
BIS T3	96
BIS T4	96
BIS T5	90
BIS T6	88
BIS T7	91
BIS T8	68
BIS T9	70
BIS T10	79
BIS T11	86
BIS T12	94
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	T8

Sensory blockade plane

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	92 min

Operation duration

92 min

4.7.Time-on

Time-on	16:30

Time-on

16:30

4.8.End time

End time	18:02

End time

18:02

4.9.Departure time

Departure time	18:10

Departure time

18:10

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	61.56 mg

Total dosage of dexmedetomidine

61.56 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	YES

Hypoxemia

YES

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	22

1 day preoperative MMSE

5.5.2.5.2.2、Postoperative day MMSE

Poseoperative day MMSE	25

Poseoperative day MMSE

5.5.2.5.2.3、Postoperative 1-day MMSE

Postoperative 1-day MMSE	26

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