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Effect of Different Doses of Dexmedetomidine on Cerebral Oxygen Saturation and Postoperative Anxiety in Elderly Patients

Primary Purpose

Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
normal saline
Sponsored by
The First Hospital of Qinhuangdao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring Dexmedetomidine, Anxiety

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients aged 65 years or older who underwent elective laparoscopic surgery under general anesthesia BMI less than 30 kg/m2 American Society of Anesthesiologists (ASA) grades I-III The score of Mini Mental state examination≥24 Exclusion Criteria: Patients with heart, lung and other vital organ disorders The score of Mini Mental state examination≤23 Preoperative psychiatric disorders or long-term use of drugs affecting the psychiatric system Have severe visual, hearing, speech impairment or other inability to communicate with the visitor Refuse to sign informed consent known preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second-degree or greater atrioventricular block without pacemaker

Sites / Locations

  • The First hosptial of QinhuangdaoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Group C

Group D1

Group D2

Arm Description

Group C received general anesthesia with intravenous normal saline. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.

groups D1 received general anesthesia with intravenous pump of 0. 2μg/kg/h dexmedetomidine. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.

groups D2 received general anesthesia with intravenous pump of 0. 5μg/kg/h dexmedetomidine. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.

Outcomes

Primary Outcome Measures

Incidence of anxiety at one day after surgery
The three groups of patients were scored on the Self-rating Anxiety Scale on the first day after surgery, and if the Self-rating Anxiety Scale score was ≥ 50 points, the patients developed anxiety, and whether the incidence of anxiety on the first day after surgery in the three groups was statistically significant.
Incidence of anxiety at three days after surgery
The three groups of patients were scored on the Self-rating Anxiety Scale on the third day after surgery, and if the Self-rating Anxiety Scale score was ≥ 50 points, the patients developed anxiety, and whether the incidence of anxiety on the third day after surgery in the three groups was statistically significant.

Secondary Outcome Measures

Anesthetic drug
The dosage of remifentanil and propofol in different groups were recorded.
The change of SBP
The change of Systolic blood pressure (SBP) among the three groups.
The change of rScO2
The change of regional cerebral oxygen saturation(rScO2) among the three groups.

Full Information

First Posted
November 26, 2022
Last Updated
December 6, 2022
Sponsor
The First Hospital of Qinhuangdao
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1. Study Identification

Unique Protocol Identification Number
NCT05640427
Brief Title
Effect of Different Doses of Dexmedetomidine on Cerebral Oxygen Saturation and Postoperative Anxiety in Elderly Patients
Official Title
Effect of Different Doses of Dexmedetomidine on Cerebral Oxygen Saturation and Postoperative Anxiety in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
March 22, 2023 (Anticipated)
Study Completion Date
March 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Qinhuangdao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the effect of different doses of dexmedetomidine on Cerebral Oxygen Saturation and Postoperative anxiety in elderly patients undergoing laparoscopic surgery
Detailed Description
A total of 105 patients who were admitted to The First Hospital of Qinhuangdao for laparoscopic surgery and divided into control group (group C), dexmedetomidine doses of 0.2 μg/kg (group D1), dexmedetomidine doses of 0.5 μg/kg (group D2). 105 patients were randomized equally into 3 groups. 35 cases in each group. Group C received general anesthesia without dexmedetomidine, groups D1 received general anesthesia with intravenous pump of 0. 2μg/kg/h dexmedetomidine, groups D2 received general anesthesia with intravenous pump of 0. 5μg/kg/h dexmedetomidine.SBP(Systolic Blood Pressure),DP(Diastolic Pressure),HR(Heart Rate) and rScO2(Regional cerebral oxygen saturation) of the three groups were recorded before anesthesia induction (T1), at the time of intubation (T2), five minutes after induction(T3),at the beginning of surgery (T4), immediately after surgery (T5), and five minutes after extubation (T6). The cognitive function of the three groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of the three groups was assessed with Self-rating Anxiety Scale (SAS) on the day before surgery,one day after and three days after surgery, comparing the incidence of anxiety between the three groups. Analyze whether dexmedetomidine reduced the incidence of anxiety by increasing cerebral oxygen saturation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Dexmedetomidine, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Group C received general anesthesia with intravenous normal saline. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.
Arm Title
Group D1
Arm Type
Experimental
Arm Description
groups D1 received general anesthesia with intravenous pump of 0. 2μg/kg/h dexmedetomidine. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.
Arm Title
Group D2
Arm Type
Experimental
Arm Description
groups D2 received general anesthesia with intravenous pump of 0. 5μg/kg/h dexmedetomidine. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Groups D1 received general anesthesia with intravenous pump of 0. 2μg/kg/h dexmedetomidine to 30min before the end of the operation.Groups D2 received general anesthesia with intravenous pump of 0. 5μg/kg/h dexmedetomidine to 30min before the end of the operation.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
The same capacity of 0.9% normal saline was used in group C
Primary Outcome Measure Information:
Title
Incidence of anxiety at one day after surgery
Description
The three groups of patients were scored on the Self-rating Anxiety Scale on the first day after surgery, and if the Self-rating Anxiety Scale score was ≥ 50 points, the patients developed anxiety, and whether the incidence of anxiety on the first day after surgery in the three groups was statistically significant.
Time Frame
One day after surgery
Title
Incidence of anxiety at three days after surgery
Description
The three groups of patients were scored on the Self-rating Anxiety Scale on the third day after surgery, and if the Self-rating Anxiety Scale score was ≥ 50 points, the patients developed anxiety, and whether the incidence of anxiety on the third day after surgery in the three groups was statistically significant.
Time Frame
Three days after surgery
Secondary Outcome Measure Information:
Title
Anesthetic drug
Description
The dosage of remifentanil and propofol in different groups were recorded.
Time Frame
Time Frame: during the surgery
Title
The change of SBP
Description
The change of Systolic blood pressure (SBP) among the three groups.
Time Frame
before anesthesia induction, at the time of intubation, at the beginning of surgery, immediately after surgery , and five minutes after extubation
Title
The change of rScO2
Description
The change of regional cerebral oxygen saturation(rScO2) among the three groups.
Time Frame
during the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients aged 65 years or older who underwent elective laparoscopic surgery under general anesthesia BMI less than 30 kg/m2 American Society of Anesthesiologists (ASA) grades I-III The score of Mini Mental state examination≥24 Exclusion Criteria: Patients with heart, lung and other vital organ disorders The score of Mini Mental state examination≤23 Preoperative psychiatric disorders or long-term use of drugs affecting the psychiatric system Have severe visual, hearing, speech impairment or other inability to communicate with the visitor Refuse to sign informed consent known preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second-degree or greater atrioventricular block without pacemaker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ximing Qi, Doctor
Phone
13731777660
Email
qhdddyyykyc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shujuan Liang, Master
Organizational Affiliation
The First hosptial of Qinhuangdao
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hua Zhou, Master
Organizational Affiliation
The First hosptial of Qinhuangdao
Official's Role
Study Chair
Facility Information:
Facility Name
The First hosptial of Qinhuangdao
City
Qinhuangdao
State/Province
Hebei
ZIP/Postal Code
066000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ximing Qi, Doctor
Phone
13731777660
Email
qhdddyyykyc@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Different Doses of Dexmedetomidine on Cerebral Oxygen Saturation and Postoperative Anxiety in Elderly Patients

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