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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640427
• Other study ID #: 2022ZH0218
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: March 22, 2023

Study information

• Verified date: December 2022
• Source: The First Hospital of Qinhuangdao
• Contact: Ximing Qi, Doctor
• Phone: 13731777660
• Email: qhdddyyykyc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effect of different doses of dexmedetomidine on Cerebral Oxygen Saturation and Postoperative anxiety in elderly patients undergoing laparoscopic surgery

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: March 22, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Drug:
• Dexmedetomidine
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 saline
The same capacity of 0.9% normal saline was used in group C

Locations

Country	Name	City	State
China	The First hosptial of Qinhuangdao	Qinhuangdao	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Qinhuangdao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One day after surgery
Primary	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.	Three days after surgery
Secondary	Anesthetic drug	The dosage of remifentanil and propofol in different groups were recorded.	Time Frame: during the surgery
Secondary	The change of SBP	The change of Systolic blood pressure (SBP) among the three groups.	before anesthesia induction, at the time of intubation, at the beginning of surgery, immediately after surgery , and five minutes after extubation
Secondary	The change of rScO2	The change of regional cerebral oxygen saturation(rScO2) among the three groups.	during the surgery