Delirium in Old AgeNCT05280860
Effect of Bilateral RSB on Postoperative Delirium in Elderly Patients Undergoing Laparoendoscopic Single-site Surgery
A study testing ultrasound-guided bilateral rectus sheath block in people with Delirium in Old Age and Hernia, Inguinal, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Postoperative delirium is a common complication in clinical surgery. It has been reported that it can increase postoperative morbidity and mortality and lead to decreased functional and cognitive abilities. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Delirium in Old Age, Hernia, Inguinal, Cholecystolithiasis
- What is being tested?
- ultrasound-guided bilateral rectus sheath block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 5 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 to 80 years male and female
- Scheduled for elective single-incision laparoscopic cholecystectomy
- The patients volunteered to participate in the study and signed the informed consent
Who cannot join
- Preexisting neuropathy
- Coagulopathy
- Local skin infection
- Hepatic, renal or cardiorespiratory failure
- Local anesthetic allergy
- Pregnancy
Show all 9Show fewer
- Complications of gallstone with gallbladder perforation
- Diffuse peritonitis
- Acute pyogenic cholangitis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 0513
Xingguo Xu, 18621526251, xxgtdfy@163.com
About this study
Official title: Effect of Bilateral Rectus Sheath Block on Postoperative Delirium in Elderly Patients Undergoing Laparoendoscopic Single-site Surgery ：A Prospective, Double-Blind, Randomized, Clinical Trial
Postoperative delirium is a common complication in clinical surgery. It has been reported that it can increase postoperative morbidity and mortality and lead to decreased functional and cognitive abilities. The aim of this study was to investigate the effect of ultrasound-guided bilateral rectus sheath blocks (RSB) on postoperative delirium in elderly patients undergoing laparoendoscopic single-site surgery (LESS) A double-blind, randomized controlled trial was conducted with 320 patients, aged 65-80 years, ASA I-III, who were scheduled to undergoing LESS in our hospital were selected, the patients divided into Group R and Group G by random number table method, with 160 patients in each group. Group R was subjected to a bilateral RSB under ultrasound guidance after general anesthesia, each side was given 0.5% ropivacaine 10 ml. Group G received simple general anesthesia.
The mini-mental State Examination was used to assess all the patients' primary cognitive status one day before surgery. Perioperative variables were recorded to be compared. The investigators used the visual analog scale to assess patients' pain degree with postoperative, using confusion assessment method to assess whether patients experienced delirium.
Read the detailed description
- Study design and setting 320 elderly patients undergoing LESS surgery under general anesthesia (including inguinal hernia and cholecystolithiasis), gender, aged 65-80 years, American Society of Anesthesiologists (ASA) physical status I-II. Exclusion criteria: MMSE of 1 day before surgery < 27, communication and dysfunction (e.g., vision, hearing), cerebrovascular history, local anesthetic allergy, opioid allergy, puncture site infection, abnormal clotting.
- Subjects Patients were allocated randomly to R group (bilateral rectus abdominis sheath blocks combined with the general anesthesia group) and G group (the simple general anesthesia group) according to computer-generated random number table. All patients and an investigator who was responsible for follow-up during 48 postoperative hours were blinded to the randomization groups. In addition, during preoperative visits, the investigators instructed patients how to use the patient-controlled intravenous analgesia (PCA) device for pain management, as well as how to use the visual analog scale to evaluate pain at rest and while coughing. All the bispectral index (BIS) value in the present study was maintained between 40 and 60 during surgery. All patients voluntarily signed informed consent.
- General anesthesia Patients were monitored by electrocardiogram, pulse oximetry and non-invasive blood pressure (one measurement every 3 min) while entering operation room. A radial artery catheter was also placed for invasive arterial pressure and blood gas monitoring. The induction of general anaesthesia was performed intravenously with sufentanil 0.5 µg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Endotracheal intubation was performed with a double-lumen tube. Sevoflurane was wsed at a minimal alveolar concentration (MAC) of 0.8-1, remifentanil and propofol were used for the maintenance. Fluid management was at the discretion of the attending anaesthesiologist.
- Conditions
- Delirium in Old Age, Hernia, Inguinal, Cholecystolithiasis
- Being tested
- ultrasound-guided bilateral rectus sheath block
- Medical subject headings
- Hernia, Inguinal, Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided bilateral rectus sheath blockProcedure or surgery
Bilateral RSB was guided by ultrasound before surgery after the completion of general anesthesia, First, the probe is placed transversely and perpendicular to reveal the anterior, hypoechoic, and posterior rectus sheath of the hyperechoic rectus abdominis. Moving the probe outward to reveal the sound images of the lateral margin of the rectus abdominis, external oblique, internal oblique, and transverse abdominis muscles. After the scanning, the needle was inserted from any segment of the probe under the guidance of real-time ultrasound; the tip reached between the rectus abdominis muscle and the posterior sheath of the rectus abdominis muscle. After no blood was extracted, 1 ~ 2 ml of normal saline was firstly injected to determine whether the tip position was correct, If the needle tip was correctly positioned, 0.5 % ropivacaine 10 mL of local anesthetic was injected on each side. The same anesthesiologist was performed bilateral RSB under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Group R: bilateral RSB under ultrasound guidance after general anesthesia | Experimental | Group R was subjected to a bilateral RSB under ultrasound guidance after general anesthesia. Receives: Procedure: ultrasound-guided bilateral rectus sheath block |
| Group G: simple general anesthesia | No intervention | Group G received simple general anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mini-mental State Examination
The mini-mental State Examination is effective as a screening tool for cognitive impairment with older, community dwelling, hospitalized and institutionalized adults. Assessment of an older adult's cognitive function is best achieved when it is done routinely, systematically and thoroughly. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.
Measured: one day before the operation.
Change from Baseline visual analogue scale
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain Visual Analogue Scale scores in post-surgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: 30 minutes after extubation and 6 hours and 12 hours
Secondary outcomes (1)
The effective times of patient-controlled intravenous analgesia
Change from Baseline patient-controlled intravenous analgesia
Measured: during 0-6 hours, 6-12 hours, and 12-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Nov 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion5 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Zhang, Principal investigator, Ethics Committee of Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280860
- Sponsor's protocol ID
- 2020-k033
- Status last verified
- Dec 2021
- First submitted
- 23 Dec 2021
- Last updated
- 4 May 2022
- Results posted
- 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 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Rectus Sheath Block on Postoperative Delirium in Elderly Patients Undergoing Laparoendoscopic Single-site Surgery ：A Prospective, Double-Blind, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT05280860
- Acronym / sponsor ID
- 2020-k033
- Conditions
- Delirium in Old Age, Hernia, Inguinal, Cholecystolithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 5 Dec 2022 (estimated)
- First posted
- 15 Mar 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.
Postoperative delirium is a common complication in clinical surgery. It has been reported that it can increase postoperative morbidity and mortality and lead to decreased functional and cognitive abilities. The aim of this study was to investigate the effect of ultrasound-guided bilateral rectus sheath blocks (RSB) on postoperative delirium in elderly patients undergoing laparoendoscopic single-site surgery (LESS) A double-blind, randomized controlled trial was conducted with 320 patients, aged 65-80 years, ASA I-III, who were scheduled to undergoing LESS in our hospital were selected, the patients divided into Group R and Group G by random number table method, with 160 patients in each group. Group R was subjected to a bilateral RSB under ultrasound guidance after general anesthesia, each side was given 0.5% ropivacaine 10 ml. Group G received simple general anesthesia.
The mini-mental State Examination was used to assess all the patients' primary cognitive status one day before surgery. Perioperative variables were recorded to be compared. The investigators used the visual analog scale to assess patients' pain degree with postoperative, using confusion assessment method to assess whether patients experienced delirium.
Detailed description
- Study design and setting 320 elderly patients undergoing LESS surgery under general anesthesia (including inguinal hernia and cholecystolithiasis), gender, aged 65-80 years, American Society of Anesthesiologists (ASA) physical status I-II. Exclusion criteria: MMSE of 1 day before surgery < 27, communication and dysfunction (e.g., vision, hearing), cerebrovascular history, local anesthetic allergy, opioid allergy, puncture site infection, abnormal clotting.
- Subjects Patients were allocated randomly to R group (bilateral rectus abdominis sheath blocks combined with the general anesthesia group) and G group (the simple general anesthesia group) according to computer-generated random number table. All patients and an investigator who was responsible for follow-up during 48 postoperative hours were blinded to the randomization groups. In addition, during preoperative visits, the investigators instructed patients how to use the patient-controlled intravenous analgesia (PCA) device for pain management, as well as how to use the visual analog scale to evaluate pain at rest and while coughing. All the bispectral index (BIS) value in the present study was maintained between 40 and 60 during surgery. All patients voluntarily signed informed consent.
- General anesthesia Patients were monitored by electrocardiogram, pulse oximetry and non-invasive blood pressure (one measurement every 3 min) while entering operation room. A radial artery catheter was also placed for invasive arterial pressure and blood gas monitoring. The induction of general anaesthesia was performed intravenously with sufentanil 0.5 µg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Endotracheal intubation was performed with a double-lumen tube. Sevoflurane was wsed at a minimal alveolar concentration (MAC) of 0.8-1, remifentanil and propofol were used for the maintenance. Fluid management was at the discretion of the attending anaesthesiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R: bilateral RSB under ultrasound guidance after general anesthesia | Experimental | Procedure: ultrasound-guided bilateral rectus sheath blockGroup R was subjected to a bilateral RSB under ultrasound guidance after general anesthesia. |
| Group G: simple general anesthesia | No intervention | –Group G received simple general anesthesia. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 to 80 years male and female
- Scheduled for elective single-incision laparoscopic cholecystectomy
- The patients volunteered to participate in the study and signed the informed consent
Key exclusion criteria (9 listed)
- Preexisting neuropathy
- Coagulopathy
- Local skin infection
- Hepatic, renal or cardiorespiratory failure
- Local anesthetic allergy
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 |
|---|---|---|
| ultrasound-guided bilateral rectus sheath blockBilateral RSB was guided by ultrasound before surgery after the completion of general anesthesia, First, the probe is placed transversely and perpendicular to reveal the anterior, hypoechoic, and posterior rectus sheath of the hyperechoic rectus abdominis. Moving the probe outward to reveal the sound images of the lateral margin of the rectus abdominis, external oblique, internal oblique, and transverse abdominis muscles. After the scanning, the needle was inserted from any segment of the probe under the guidance of real-time ultrasound; the tip reached between the rectus abdominis muscle and the posterior sheath of the rectus abdominis muscle. After no blood was extracted, 1 ~ 2 ml of normal saline was firstly injected to determine whether the tip position was correct, If the needle tip was correctly positioned, 0.5 % ropivacaine 10 mL of local anesthetic was injected on each side. The same anesthesiologist was performed bilateral RSB under ultrasound guidance. | Procedure or surgery | Group R: bilateral RSB under ultrasound guidance after general anesthesia |
Primary outcome
The mini-mental State Examination
Time frame: one day before the operation.
The mini-mental State Examination is effective as a screening tool for cognitive impairment with older, community dwelling, hospitalized and institutionalized adults. Assessment of an older adult's cognitive function is best achieved when it is done routinely, systematically and thoroughly. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.
Change from Baseline visual analogue scale
Time frame: 30 minutes after extubation and 6 hours and 12 hours
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain Visual Analogue Scale scores in post-surgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
1 secondary outcome
The effective times of patient-controlled intravenous analgesia
Time frame: during 0-6 hours, 6-12 hours, and 12-24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- 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.
Tao Zhang principal investigator
Ethics Committee of Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided bilateral rectus sheath block in people with Delirium in Old Age and Hernia, Inguinal, run by Affiliated Hospital of Nantong University 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 May 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xingguo Xu, Dr. (18621526251, xxgtdfy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mini-mental State Examination (time frame: one day before the operation.). 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 4 May 2022.