Amobarbital SodiumPhase 4NCT06385756
Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions
A Phase 4 study testing Amobarbital and Propofol in people with Amobarbital Sodium and Hemodynamics Instability, run by Tongji Hospital.
Trial summary
At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Amobarbital Sodium, Hemodynamics Instability
- What is being tested?
- Amobarbital and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2026
- Phase
- Phase 4
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 40~60 years old；
- ASA Class I to II；
- The operation time was 1h~2h；
- BMI 18~25；
- Sign informed consent.
Who cannot join
- Known allergy to narcotic drugs used in this study;
- Severe pulmonary insufficiency;
- Abnormal liver and kidney function；
- History of severe anemia and hematoporphyrin；
- History of asthma;
- Uncontrolled high blood pressure or diabetes;
- Pregnant and lactating women；
- Accompanied by cognitive impairment or inability to communicate.
About this study
Official title: Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions in Gynecological Laparoscopic Surgery
At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.
The main questions it aims to answer are:
Read more
- whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;
- whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.
Participants will:
- Induction of anesthesia with the experimental drug or placebo；
- 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；
- To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded.
- Conditions
- Amobarbital Sodium, Hemodynamics Instability
- Being tested
- Amobarbital, Propofol
- Keywords
- Anesthesia induction, Perioperative Adverse Reactions, Gynecological Laparoscopic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmobarbitalDrug
Participants with gynecological laparoscopic surgery who met the trial inclusion criteria were randomly divided into 2 groups. After entering the room, peripheral intravenous infusion was opened and oxygen was absorbed by the mask for 5 L/min. Mean arterial pressure, heart rate and oxygen saturation were routinely monitored. After positioning, the amobarbital-propofol group was given amobarbital sodium 1 mg/kg 1 min before induction, followed by Sufentanil 0.5ug /kg, cisatracurium 0.2mg /kg, penehyclidine hydrochloride 0.01mg /kg, propofol 1.5mg /kg for general anesthesia induction. The propofol group was given the same volume of normal saline 1 min before anesthesia induction, followed by Sufentanil 0.5ug /kg, cisatracurium 0.2mg /kg, penehyclidine hydrochloride 0.01mg /kg, propofol 2.5mg /kg.
PropofolDrug
propofol
| Study group | Role | What they receive |
|---|---|---|
| amobarbital-propofol group | Experimental | Participants were given amobarbital sodium 1 mg/kg 1 min before induction and propofol 1.5mg /kg following. Receives: Drug: Amobarbital; Drug: Propofol |
| propofol group | Placebo comparator | The propofol group was given the same volume of normal saline 1 min before induction, followed by propofol 2.5mg /kg. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure (MAP) during Induction of anesthesia
MAP was recorded as the main index of hemodynamics during anesthesia induction
Measured: Up to 3 hours
Secondary outcomes (2)
MAP at different time points
MAP at different time points (including before induction, tracheal intubation, cutting the skin, extubation)
Measured: Up to 3 hours
Incidence of postoperative nausea and vomiting (ponv)
The incidence of perioperative adverse reactions (ponv) was recorded
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amobarbital SodiumStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuebi Tian, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385756
- Sponsor's protocol ID
- TJ-IRB202403020
- Status last verified
- May 2024
- First submitted
- 17 Apr 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions in Gynecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06385756
- Acronym / sponsor ID
- TJ-IRB202403020
- Conditions
- Amobarbital Sodium, Hemodynamics Instability
- Keywords
- Anesthesia induction, Perioperative Adverse Reactions, Gynecological Laparoscopic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 26 Apr 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.
At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.
The main questions it aims to answer are:
- whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;
- whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.
Participants will:
- Induction of anesthesia with the experimental drug or placebo；
- 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；
- To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amobarbital-propofol group | Experimental | Drug: Amobarbital, Drug: PropofolParticipants were given amobarbital sodium 1 mg/kg 1 min before induction and propofol 1.5mg /kg following. |
| propofol group | Placebo comparator | Drug: PropofolThe propofol group was given the same volume of normal saline 1 min before induction, followed by propofol 2.5mg /kg. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 40~60 years old；
- ASA Class I to II；
- The operation time was 1h~2h；
- BMI 18~25；
- Sign informed consent.
Key exclusion criteria (8 listed)
- Known allergy to narcotic drugs used in this study;
- Severe pulmonary insufficiency;
- Abnormal liver and kidney function；
- History of severe anemia and hematoporphyrin；
- History of asthma;
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 |
|---|---|---|
| AmobarbitalParticipants with gynecological laparoscopic surgery who met the trial inclusion criteria were randomly divided into 2 groups. After entering the room, peripheral intravenous infusion was opened and oxygen was absorbed by the mask for 5 L/min. Mean arterial pressure, heart rate and oxygen saturation were routinely monitored. After positioning, the amobarbital-propofol group was given amobarbital sodium 1 mg/kg 1 min before induction, followed by Sufentanil 0.5ug /kg, cisatracurium 0.2mg /kg, penehyclidine hydrochloride 0.01mg /kg, propofol 1.5mg /kg for general anesthesia induction. The propofol group was given the same volume of normal saline 1 min before anesthesia induction, followed by Sufentanil 0.5ug /kg, cisatracurium 0.2mg /kg, penehyclidine hydrochloride 0.01mg /kg, propofol 2.5mg /kg. | Drug | amobarbital-propofol group |
| Propofolpropofol | Drug | amobarbital-propofol group, propofol group |
Primary outcome
Mean arterial pressure (MAP) during Induction of anesthesia
Time frame: Up to 3 hours
MAP was recorded as the main index of hemodynamics during anesthesia induction
2 secondary outcomes
MAP at different time points
Time frame: Up to 3 hours
Incidence of postoperative nausea and vomiting (ponv)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amobarbital and Propofol in people with Amobarbital Sodium and Hemodynamics Instability, run by Tongji Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Mean arterial pressure (MAP) during Induction of anesthesia (time frame: Up to 3 hours). 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 22 May 2024.