Laparoscopic SurgeryNCT06669689
The Impact of Anesthesia and Positioning on Cerebral Blood Flow and Pressure in Patients Undergoing Laparoscopic Surgery
An observational study of Laparoscopic Surgery, run by Xiaguang Duan at 1 site in China.
Trial summary
The aim of this observational study was to understand the effect of ReverseTrendelenburg position, Trendelenburg position on intracranial pressure and carotid blood flow in patients undergoing laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 29 to 62 years, women only
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- operating position and pneumoperitoneum
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 29 to 62 years
- Women only
- No healthy volunteers
- Adult
Study population: Between February 2023 and December 2023, 76 patients, all classified as ASA I-II adults, were selected at Baogang Hospital, Inner Mongolia.
Who may be able to join
- agreed to participate and signed informed consent forms
- classified as ASA I-II adults
Who cannot join
- allergy to anesthetics
- refused to sign the consent form or were uncooperative
- a body mass index (BMI) ≥30 kg m-2
- uncontrolled hypertension
- uncontrolled diabetes
- cirrhosis or renal impairment
- cardiopulmonary insufficiency
- persistent eye infections, or a history of ophthalmic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Anesthesia and Positioning on Cerebral Blood Flow and Pressure in Patients Undergoing Laparoscopic Surgery: an Observational Study
The aim of this observational study was to understand the effect of ReverseTrendelenburg position, Trendelenburg position on intracranial pressure and carotid blood flow in patients undergoing laparoscopic surgery. The main question it aims to answer is:
Does ReverseTrendelenburg position increase common carotid artery (CCA) flow, optic nerve sheath diameter (ONSD); does Trendelenburg position decrease CCA flow, ONSD.
Read the detailed description
This study was approved by the Medical Ethics Committee of Inner Mongolia Baogang Hospital, on January 11, 2023 (2023-MER-26),follow the Declaration of Helsinki. All participants voluntarily agreed to participate and signed informed consent forms. Between February 2023 and December 2023, 76 patients, all classified as ASA I-II adults, were selected at Baogang Hospital, Inner Mongolia. Patients were excluded if they had an allergy to anesthetics used in this study or experienced adverse reactions to analgesics included in the study. Patients were deemed ineligible for clinical evaluation if they refused to sign the consent form or were uncooperative. We excluded patients with a body mass index (BMI) ≥30 kg m-2, uncontrolled hypertension, uncontrolled diabetes, cirrhosis or renal impairment, cardiopulmonary insufficiency, cerebrovascular disease, glaucoma, persistent eye infections, or a history of ophthalmic surgery.
Upon entering the operating room, patients were monitored for pulse oximetry, ECG, BIS, and non-invasive arterial blood pressure. Prior to surgery, patients were administered Penehyclidine Hydrochloride Injection (Lot H20051948, Chengdu List Pharmaceutical Co., Ltd., China) at a dose of 0.01 mg kg-1i.v.. Patients were induced with propofol (1.5-2 mg kg-1i.v.), rocuronium (1-2 mg kg-1i.v.), and fentanyl (1-2μg kg-1i.v.). Anesthesia was maintained with inhaled sevoflurane or desflurane, with inhalation concentrations adjusted according to BIS. Remifentanil (0.05-0.2μg kg-1 min-1i.v.) was continuously infused, with blood pressure and heart rate adjusted to ±20% of baseline values. After induction, patients were mechanically ventilated using the Pressure-Regulated Volume Control (PRVC) mode. Ventilator parameters were set as tidal volume 6-8 ml kg-1, PEEP 0 cmH2O, I ratio of 1:2, respiratory rate 16 breaths per minute (BPM), and FiO2 of 41%. In the Trendelenburg position, the operating table was tilted head down at an angle of 20-25°. In the Reverse Trendelenburg position, the operating table was tilted head up at an angle of 20-25°. Pneumoperitoneum was established with an intra-abdominal pressure of 10-15 mmHg.
Measurements were recorded at five time points: before anesthesia (T1), after intubation (T2), after position change (Trendelenburg or Reverse Trendelenburg position) (T3), after pneumoperitoneum (T4), and at the end of surgery (T5)( Fig 1 b). Parameters measured included mean arterial pressure (MAP; calculated as diastolic pressure + 1/3 pulse pressure), heart rate (HR), Bispectral Index (BIS), PIP, end-tidal carbon dioxide (ETCO2), tidal volume (TV), common carotid artery (CCA) flow, CCA beat volume, CCA diameter, and optic nerve sheath diameter (ONSD). CCA flow, CCA beat volume, CCA diameter, and ONSD were measured using ultrasound by a trained researcher. Ultrasound measurements were performed using the LOGIQ™ E20 device (GE Healthcare, Chicago, Illinois, USA) equipped with a linear 7.5 MHz ultrasound transducer (GE Healthcare, Chicago, Illinois, USA) and a 2.5 MHz ultrasound transducer (GE Healthcare, Chicago, Illinois, USA) to assess optic nerve sheath diameter and common carotid artery blood flow. For each time point, three measurements were taken, and the average value was recorded. Other data were recorded by the anesthesiologist or anesthesia nurse.
In the Postanesthetic Care Unit (PACU), the following parameters were monitored and recorded: length of stay, mean arterial pressure, heart rate, postoperative nausea and vomiting, pain, rescue antiemetics, rescue analgesics, and rescue sulfentanil dose.
- Conditions
- Laparoscopic Surgery
- Being tested
- operating position, pneumoperitoneum
- Keywords
- intracranial pressure, laparoscopic, optic nerve sheath diameter, ReverseTrendelenburg position, Trendelenburg position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operating positionDevice
Also called the Trendelenburg position, the Reverse Trendelenburg position
In the Trendelenburg position, the operating table was tilted head down at an angle of 20-25°. In the Reverse Trendelenburg position, the operating table was tilted head up at an angle of 20-25°.
pneumoperitoneumDevice
Pneumoperitoneum was established with an intra-abdominal pressure of 10-15 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| the TREND group (Trendelenburg position) | In the Trendelenburg position, the operating table was tilted head down at an angle of 20-25°. Receives: Device: operating position; Device: pneumoperitoneum | |
| the Reverse Trendelenburg position | In the Reverse Trendelenburg position, the operating table was tilted head up at an angle of 20-25° Receives: Device: operating position; Device: pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
common carotid artery (CCA) flow
If it was significantly lower than pre-anesthetic, it was considered that the position and pneumoperitoneum affected the cerebral blood supply.
Measured: From February 2023 to December 2023
Secondary outcomes (1)
optic nerve sheath diameter (ONSD)
If significantly higher than pre-anesthetic, it is thought that the position and pneumoperitoneum have increased intracranial pressure.
Measured: From February 2023 to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Feb 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Xiaguang Duan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaguang Duan, Inner Mongolia Baogang Hospital
- Investigators
- Xiangyu Wang, undergraduate, Principal investigator, Inner Mongolia Baogang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669689
- Sponsor's protocol ID
- 2023-MER-26
- Status last verified
- Jan 2023
- First submitted
- 28 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Recorded parameters were taken at five time points: before anesthesia (T1), after intubation (T2), after positional change (Trendelenburg or Reverse Trendelenburg) (T3), after pneumoperitoneum (T4), and at the end of surgery (T5). Recorded parameters included mean arterial pressure (MAP), heart rate (HR), Bispectral index(BIS), Peak inspiratory pressure (PIP), end-tidal carbon dioxide concentration (ETCO2), Total volume (TV), common carotid artery (CCA) flow, CCA beat volume, CCA diameter, and optic nerve sheath diameter (ONSD).
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Anesthesia and Positioning on Cerebral Blood Flow and Pressure in Patients Undergoing Laparoscopic Surgery: an Observational Study
- ClinicalTrials.gov ID
- NCT06669689
- Acronym / sponsor ID
- 2023-MER-26
- Conditions
- Laparoscopic Surgery
- Keywords
- intracranial pressure, laparoscopic, optic nerve sheath diameter, ReverseTrendelenburg position, Trendelenburg position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xiaguang DuanUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 1 Nov 2024 (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.
The aim of this observational study was to understand the effect of ReverseTrendelenburg position, Trendelenburg position on intracranial pressure and carotid blood flow in patients undergoing laparoscopic surgery. The main question it aims to answer is:
Does ReverseTrendelenburg position increase common carotid artery (CCA) flow, optic nerve sheath diameter (ONSD); does Trendelenburg position decrease CCA flow, ONSD.
Detailed description
This study was approved by the Medical Ethics Committee of Inner Mongolia Baogang Hospital, on January 11, 2023 (2023-MER-26),follow the Declaration of Helsinki. All participants voluntarily agreed to participate and signed informed consent forms. Between February 2023 and December 2023, 76 patients, all classified as ASA I-II adults, were selected at Baogang Hospital, Inner Mongolia. Patients were excluded if they had an allergy to anesthetics used in this study or experienced adverse reactions to analgesics included in the study. Patients were deemed ineligible for clinical evaluation if they refused to sign the consent form or were uncooperative. We excluded patients with a body mass index (BMI) ≥30 kg m-2, uncontrolled hypertension, uncontrolled diabetes, cirrhosis or renal impairment, cardiopulmonary insufficiency, cerebrovascular disease, glaucoma, persistent eye infections, or a history of ophthalmic surgery.
Upon entering the operating room, patients were monitored for pulse oximetry, ECG, BIS, and non-invasive arterial blood pressure. Prior to surgery, patients were administered Penehyclidine Hydrochloride Injection (Lot H20051948, Chengdu List Pharmaceutical Co., Ltd., China) at a dose of 0.01 mg kg-1i.v.. Patients were induced with propofol (1.5-2 mg kg-1i.v.), rocuronium (1-2 mg kg-1i.v.), and fentanyl (1-2μg kg-1i.v.). Anesthesia was maintained with inhaled sevoflurane or desflurane, with inhalation concentrations adjusted according to BIS. Remifentanil (0.05-0.2μg kg-1 min-1i.v.) was continuously infused, with blood pressure and heart rate adjusted to ±20% of baseline values. After induction, patients were mechanically ventilated using the Pressure-Regulated Volume Control (PRVC) mode. Ventilator parameters were set as tidal volume 6-8 ml kg-1, PEEP 0 cmH2O, I ratio of 1:2, respiratory rate 16 breaths per minute (BPM), and FiO2 of 41%. In the Trendelenburg position, the operating table was tilted head down at an angle of 20-25°. In the Reverse Trendelenburg position, the operating table was tilted head up at an angle of 20-25°. Pneumoperitoneum was established with an intra-abdominal pressure of 10-15 mmHg.
Measurements were recorded at five time points: before anesthesia (T1), after intubation (T2), after position change (Trendelenburg or Reverse Trendelenburg position) (T3), after pneumoperitoneum (T4), and at the end of surgery (T5)( Fig 1 b). Parameters measured included mean arterial pressure (MAP; calculated as diastolic pressure + 1/3 pulse pressure), heart rate (HR), Bispectral Index (BIS), PIP, end-tidal carbon dioxide (ETCO2), tidal volume (TV), common carotid artery (CCA) flow, CCA beat volume, CCA diameter, and optic nerve sheath diameter (ONSD). CCA flow, CCA beat volume, CCA diameter, and ONSD were measured using ultrasound by a trained researcher. Ultrasound measurements were performed using the LOGIQ™ E20 device (GE Healthcare, Chicago, Illinois, USA) equipped with a linear 7.5 MHz ultrasound transducer (GE Healthcare, Chicago, Illinois, USA) and a 2.5 MHz ultrasound transducer (GE Healthcare, Chicago, Illinois, USA) to assess optic nerve sheath diameter and common carotid artery blood flow. For each time point, three measurements were taken, and the average value was recorded. Other data were recorded by the anesthesiologist or anesthesia nurse.
In the Postanesthetic Care Unit (PACU), the following parameters were monitored and recorded: length of stay, mean arterial pressure, heart rate, postoperative nausea and vomiting, pain, rescue antiemetics, rescue analgesics, and rescue sulfentanil dose.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the TREND group (Trendelenburg position) | – | Device: operating position, Device: pneumoperitoneumIn the Trendelenburg position, the operating table was tilted head down at an angle of 20-25°. |
| the Reverse Trendelenburg position | – | Device: operating position, Device: pneumoperitoneumIn the Reverse Trendelenburg position, the operating table was tilted head up at an angle of 20-25° |
Who may qualify
- Ages
- 29 to 62 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Between February 2023 and December 2023, 76 patients, all classified as ASA I-II adults, were selected at Baogang Hospital, Inner Mongolia.
Key inclusion criteria (2 listed)
- agreed to participate and signed informed consent forms
- classified as ASA I-II adults
Key exclusion criteria (8 listed)
- allergy to anesthetics
- refused to sign the consent form or were uncooperative
- a body mass index (BMI) ≥30 kg m-2
- uncontrolled hypertension
- uncontrolled diabetes
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 |
|---|---|---|
| operating positionAlso: the Trendelenburg position, the Reverse Trendelenburg positionIn the Trendelenburg position, the operating table was tilted head down at an angle of 20-25°. In the Reverse Trendelenburg position, the operating table was tilted head up at an angle of 20-25°. | Device | the Reverse Trendelenburg position, the TREND group (Trendelenburg position) |
| pneumoperitoneumPneumoperitoneum was established with an intra-abdominal pressure of 10-15 mmHg. | Device | the Reverse Trendelenburg position, the TREND group (Trendelenburg position) |
Primary outcome
common carotid artery (CCA) flow
Time frame: From February 2023 to December 2023
If it was significantly lower than pre-anesthetic, it was considered that the position and pneumoperitoneum affected the cerebral blood supply.
1 secondary outcome
optic nerve sheath diameter (ONSD)
Time frame: From February 2023 to December 2023
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 1 Nov 2024.
- Individual participant dataSharing planned: Yes. Recorded parameters were taken at five time points: before anesthesia (T1), after intubation (T2), after positional change (Trendelenburg or Reverse Trendelenburg) (T3), after pneumoperitoneum (T4), and at the end of surgery (T5). Recorded parameters included mean arterial pressure (MAP), heart rate (HR), Bispectral index(BIS), Peak inspiratory pressure (PIP), end-tidal carbon dioxide concentration (ETCO2), Total volume (TV), common carotid artery (CCA) flow, CCA beat volume, CCA diameter, and optic nerve sheath diameter (ONSD).
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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.
Xiangyu Wang, undergraduate principal investigator
Inner Mongolia Baogang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Surgery, run by Xiaguang Duan 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 2 inclusion and 8 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 1 Nov 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. 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?
common carotid artery (CCA) flow (time frame: From February 2023 to December 2023). 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 1 Nov 2024.