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	75 years old

2.2.Weight

Weight	55 kg

Weight

55 kg

2.3.Height

Height	1.72 m

Height

1.72 m

2.4.BMI

BMI	18.59 kg/m2

2.5.Degree of education

Degree of education	Primary school

Degree of education

Primary 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	135 mmHg
Systolic pressure T2	143 mmHg
Systolic pressure T3	157 mmHg
Systolic pressure T4	143 mmHg
Systolic pressure T5	146 mmHg
Systolic pressure T6	123 mmHg
Systolic pressure T7	126 mmHg
Systolic pressure T8	134 mmHg
Systolic pressure T9	123 mmHg
Systolic pressure T10	121 mmHg
Systolic pressure T11	126 mmHg
Systolic pressure T12	122 mmHg
Systolic pressure T13	111 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	55 mmHg
Diastolic pressure T2	67 mmHg
Diastolic pressure T3	69 mmHg
Diastolic pressure T4	73 mmHg
Diastolic pressure T5	69 mmHg
Diastolic pressure T6	72 mmHg
Diastolic pressure T7	73 mmHg
Diastolic pressure T8	73 mmHg
Diastolic pressure T9	74 mmHg
Diastolic pressure T10	71 mmHg
Diastolic pressure T11	74 mmHg
Diastolic pressure T12	73 mmHg
Diastolic pressure T13	67 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	81 mmHg
Mean arterial pressure T2	84 mmHg
Mean arterial pressure T3	91 mmHg
Mean arterial pressure T4	89 mmHg
Mean arterial pressure T5	98 mmHg
Mean arterial pressure T6	85 mmHg
Mean arterial pressure T7	96 mmHg
Mean arterial pressure T8	95 mmHg
Mean arterial pressure T9	88 mmHg
Mean arterial pressure T10	90 mmHg
Mean arterial pressure T11	90 mmHg
Mean arterial pressure T12	88 mmHg
Mean arterial pressure T13	78 mmHg

3.4.Heart rate

Heart rate T1	61 times/min
Heart rate T2	62 times/min
Heart rate T3	59 times/min
Heart rate T4	54 times/min
Heart rate T5	49 times/min
Heart rate T6	46 times/min
Heart rate T7	46 times/min
Heart rate T8	49 times/min
Heart rate T9	50 mmHg
Heart rate T10	50 times/min
Heart rate T11	47 times/min
Heart rate T12	45 times/min
Heart rate T13	46 times/min

3.5.Respiratory rate

Respiratory rate T1	17 times/min
Respiratory rate T2	19 times/min
Respiratory rate T3	19 times/min
Respiratory rate T4	16 times/min
Respiratory rate T5	14 times/min
Respiratory rate T6	15 times/min
Respiratory rate T7	15 times/min
Respiratory rate T8	13 times/min
Respiratory rate T9	16 times/min
Respiratory rate T10	14 times/min
Respiratory rate T11	13 times/min
Respiratory rate T12	13 times/min
Respiratory rate T13	13 times/min

3.6.Oxygen saturation

Oxygen saturation T1	97 %
Oxygen saturation T2	98 %
Oxygen saturation T3	99 %
Oxygen saturation T4	98 %
Oxygen saturation T5	99 %
Oxygen saturation T6	95 %
Oxygen saturation T7	95 %
Oxygen saturation T8	97 %
Oxygen saturation T9	91 %
Oxygen saturation T10	94 %
Oxygen saturation T11	98 %
Oxygen saturation T12	98 %
Oxygen saturation T13	98 %

3.7.BIS

BIS T1	92
BIS T2	94
BIS T3	97
BIS T4	94
BIS T5	90
BIS T6	88
BIS T7	90
BIS T8	85
BIS T9	80
BIS T10	74
BIS T11	96
BIS T12	88
BIS T13	94

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	87 min

Operation duration

87 min

4.7.Time-on

Time-on	08:32

Time-on

08:32

4.8.End time

End time	09:59

End time

09:59

4.9.Departure time

Departure time	10:08

Departure time

10:08

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	34.815 mg

Total dosage of dexmedetomidine

34.815 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	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	29

Poseoperative day MMSE

5.5.2.5.2.3、Postoperative 1-day MMSE

Postoperative 1-day MMSE	29

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