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	76 years old

2.2.Weight

Weight	72.5 kg

Weight

72.5 kg

2.3.Height

Height	1.78 m

Height

1.78 m

2.4.BMI

BMI	22.88 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	147 mmHg
Systolic pressure T2	134 mmHg
Systolic pressure T3	146 mmHg
Systolic pressure T4	136 mmHg
Systolic pressure T5	130 mmHg
Systolic pressure T6	120 mmHg
Systolic pressure T7	129 mmHg
Systolic pressure T8	118 mmHg
Systolic pressure T9	111 mmHg
Systolic pressure T10	114 mmHg
Systolic pressure T11	122 mmHg
Systolic pressure T12	121 mmHg
Systolic pressure T13	115 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	82 mmHg
Diastolic pressure T2	78 mmHg
Diastolic pressure T3	91 mmHg
Diastolic pressure T4	82 mmHg
Diastolic pressure T5	77 mmHg
Diastolic pressure T6	74 mmHg
Diastolic pressure T7	70 mmHg
Diastolic pressure T8	77 mmHg
Diastolic pressure T9	69 mmHg
Diastolic pressure T10	71 mmHg
Diastolic pressure T11	74 mmHg
Diastolic pressure T12	75 mmHg
Diastolic pressure T13	73 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	103 mmHg
Mean arterial pressure T2	98 mmHg
Mean arterial pressure T3	109 mmHg
Mean arterial pressure T4	100 mmHg
Mean arterial pressure T5	98 mmHg
Mean arterial pressure T6	82 mmHg
Mean arterial pressure T7	81 mmHg
Mean arterial pressure T8	87 mmHg
Mean arterial pressure T9	83 mmHg
Mean arterial pressure T10	85 mmHg
Mean arterial pressure T11	90 mmHg
Mean arterial pressure T12	94 mmHg
Mean arterial pressure T13	86 mmHg

3.4.Heart rate

Heart rate T1	59 times/min
Heart rate T2	63 times/min
Heart rate T3	62 times/min
Heart rate T4	56 times/min
Heart rate T5	51 times/min
Heart rate T6	48 times/min
Heart rate T7	48 times/min
Heart rate T8	47 times/min
Heart rate T9	46 mmHg
Heart rate T10	46 times/min
Heart rate T11	45 times/min
Heart rate T12	46 times/min
Heart rate T13	47 times/min

3.5.Respiratory rate

Respiratory rate T1	15 times/min
Respiratory rate T2	15 times/min
Respiratory rate T3	16 times/min
Respiratory rate T4	15 times/min
Respiratory rate T5	15 times/min
Respiratory rate T6	16 times/min
Respiratory rate T7	9 times/min
Respiratory rate T8	15 times/min
Respiratory rate T9	14 times/min
Respiratory rate T10	15 times/min
Respiratory rate T11	14 times/min
Respiratory rate T12	14 times/min
Respiratory rate T13	15 times/min

3.6.Oxygen saturation

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

3.7.BIS

BIS T1	96
BIS T2	95
BIS T3	96
BIS T4	86
BIS T5	94
BIS T6	63
BIS T7	71
BIS T8	53
BIS T9	53
BIS T10	49
BIS T11	71
BIS T12	85
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	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	84 min

Operation duration

84 min

4.7.Time-on

Time-on	08:55

Time-on

08:55

4.8.End time

End time	10:19

End time

10:19

4.9.Departure time

Departure time	10:29

Departure time

10:29

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	46.04 mg

Total dosage of dexmedetomidine

46.04 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	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	28

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