AnxietyNCT05640427
Effect of Different Doses of Dexmedetomidine on Cerebral Oxygen Saturation and Postoperative Anxiety in Elderly Patients
A study testing Dexmedetomidine and normal saline in people with Anxiety, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
To investigate the effect of different doses of dexmedetomidine on Cerebral Oxygen Saturation and Postoperative anxiety in elderly patients undergoing laparoscopic surgery Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2022to 22 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of different doses of dexmedetomidine on Cerebral Oxygen Saturation and Postoperative anxiety in elderly patients undergoing laparoscopic surgery
Read the 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.
- Conditions
- Anxiety
- Being tested
- Dexmedetomidine, normal saline
- Keywords
- Dexmedetomidine, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
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.
normal salineDrug
The same capacity of 0.9% normal saline was used in group C
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | 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. Receives: Drug: normal saline |
| Group D1 | Experimental | 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. Receives: Drug: Dexmedetomidine |
| Group D2 | Experimental | 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day after surgery
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.
Measured: Three days after surgery
Secondary outcomes (3)
Anesthetic drug
The dosage of remifentanil and propofol in different groups were recorded.
Measured: Time Frame: during the surgery
The change of SBP
The change of Systolic blood pressure (SBP) among the three groups.
Measured: before anesthesia induction, at the time of intubation, at the beginning of surgery, immediately after surgery , and five minutes after extubation
The change of rScO2
The change of regional cerebral oxygen saturation(rScO2) among the three groups.
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start22 Mar 2022
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shujuan Liang, Master, Study director, The First hosptial of QinhuangdaoHua Zhou, Master, Study chair, The First hosptial of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640427
- Sponsor's protocol ID
- 2022ZH0218
- Status last verified
- Dec 2022
- First submitted
- 26 Nov 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Doses of Dexmedetomidine on Cerebral Oxygen Saturation and Postoperative Anxiety in Elderly Patients
- ClinicalTrials.gov ID
- NCT05640427
- Acronym / sponsor ID
- 2022ZH0218
- Conditions
- Anxiety
- Keywords
- Dexmedetomidine, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Drug: normal salineGroup 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. |
| Group D1 | Experimental | Drug: Dexmedetomidinegroups 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. |
| Group D2 | Experimental | Drug: Dexmedetomidinegroups 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineGroups 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. | Drug | Group D1, Group D2 |
| normal salineThe same capacity of 0.9% normal saline was used in group C | Drug | Group C |
Primary outcome
Incidence of anxiety at one day after surgery
Time frame: 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
Time frame: 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.
3 secondary outcomes
Anesthetic drug
Time frame: Time Frame: during the surgery
The change of SBP
Time frame: before anesthesia induction, at the time of intubation, at the beginning of surgery, immediately after surgery , and five minutes after extubation
The change of rScO2
Time frame: during the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shujuan Liang, Master study director
The First hosptial of Qinhuangdao
Hua Zhou, Master study chair
The First hosptial of Qinhuangdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and normal saline in people with Anxiety, run by The First Hospital of Qinhuangdao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of anxiety at one day after surgery (time frame: One day after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.