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	65 years old

2.2.Weight

Weight	67.5 kg

Weight

67.5 kg

2.3.Height

Height	1.70 m

Height

1.70 m

2.4.BMI

BMI	23.36 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	Hypertention / Diabetes

Underlying disease

Hypertention

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	183 mmHg
Systolic pressure T2	177 mmHg
Systolic pressure T3	176 mmHg
Systolic pressure T4	173 mmHg
Systolic pressure T5	177 mmHg
Systolic pressure T6	165 mmHg
Systolic pressure T7	144 mmHg
Systolic pressure T8	140 mmHg
Systolic pressure T9	138 mmHg
Systolic pressure T10	129 mmHg
Systolic pressure T11	151 mmHg
Systolic pressure T12	159 mmHg
Systolic pressure T13	147 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	102 mmHg
Diastolic pressure T2	99 mmHg
Diastolic pressure T3	98 mmHg
Diastolic pressure T4	99 mmHg
Diastolic pressure T5	102 mmHg
Diastolic pressure T6	94 mmHg
Diastolic pressure T7	93 mmHg
Diastolic pressure T8	86 mmHg
Diastolic pressure T9	87 mmHg
Diastolic pressure T10	83 mmHg
Diastolic pressure T11	87 mmHg
Diastolic pressure T12	90 mmHg
Diastolic pressure T13	92 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	133 mmHg
Mean arterial pressure T2	135 mmHg
Mean arterial pressure T3	124 mmHg
Mean arterial pressure T4	123 mmHg
Mean arterial pressure T5	127 mmHg
Mean arterial pressure T6	117 mmHg
Mean arterial pressure T7	113 mmHg
Mean arterial pressure T8	107 mmHg
Mean arterial pressure T9	107 mmHg
Mean arterial pressure T10	102 mmHg
Mean arterial pressure T11	118 mmHg
Mean arterial pressure T12	120 mmHg
Mean arterial pressure T13	130 mmHg

3.4.Heart rate

Heart rate T1	87 times/min
Heart rate T2	89 times/min
Heart rate T3	81 times/min
Heart rate T4	85 times/min
Heart rate T5	89 times/min
Heart rate T6	83 times/min
Heart rate T7	75 times/min
Heart rate T8	69 times/min
Heart rate T9	72 mmHg
Heart rate T10	69 times/min
Heart rate T11	65 times/min
Heart rate T12	72 times/min
Heart rate T13	77 times/min

3.5.Respiratory rate

Respiratory rate T1	17 times/min
Respiratory rate T2	17 times/min
Respiratory rate T3	14 times/min
Respiratory rate T4	16 times/min
Respiratory rate T5	16 times/min
Respiratory rate T6	25 times/min
Respiratory rate T7	20 times/min
Respiratory rate T8	21 times/min
Respiratory rate T9	17 times/min
Respiratory rate T10	18 times/min
Respiratory rate T11	14 times/min
Respiratory rate T12	10 times/min
Respiratory rate T13	12 times/min

3.6.Oxygen saturation

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

3.7.BIS

BIS T1	97
BIS T2	89
BIS T3	98
BIS T4	95
BIS T5	98
BIS T6	92
BIS T7	96
BIS T8	95
BIS T9	93
BIS T10	93
BIS T11	87
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	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	3

A-VAS

4.6.Operation duration

Operation duration	97 min

Operation duration

97 min

4.7.Time-on

Time-on	17:00

Time-on

17:00

4.8.End time

End time	18:37

End time

18:37

4.9.Departure time

Departure time	18:45

Departure time

18:45

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	29

1 day preoperative STAI-S

5.5.1.5.1.2、Postoperative day STAI-S

Postoperative day STAI-S	21

Postoperative day STAI-S

5.2.

5.5.2.5.2.1、1 day preoperative MMSE

1 day preoperative MMSE	28

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