AnesthesiaNCT05420402
Effect of Different Administrations of Propofol on Emergence Agitation in Preschool Children Undergoing Ambulatory Surgery
A study testing Propofol bolus and Propofol continuous infusion in people with Anesthesia and Surgery, run by Jiaxiang Chen at 1 site in China.
Trial summary
This study evaluates the influence of different dose and methods of propofol on emergence agitation(EA) through a randomized controlled trial when preschool children undergoing ambulatory surgery of inguinal hernia. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Surgery
- What is being tested?
- Propofol bolus and Propofol continuous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Jun 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 2-5 years
- ASA classification 1
- Written informed consent
- Children undergoing ambulatory surgery of inguinal hernia
- The operation will take no more than 20 minutes
Who cannot join
- Allergic to drugs used in the study
- Neurological disorders
- Congenital heart insufficiency
- Recent respiratory illness
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the influence of different dose and methods of propofol on emergence agitation(EA) through a randomized controlled trial when preschool children undergoing ambulatory surgery of inguinal hernia.
Read the detailed description
Emergency agitation (EA) is the manifestation of excitement, high irritability, intense struggle, and increased blood pressure and heart rate during the recovery period of general anesthesia. It is a common adverse reaction after general anesthesia. The incidence in preschool children is 10%-80%, which is currently considered to be mainly related to factors such as the use of inhalation anesthetics, pain stimulation, drug types, surgical methods, and environmental changes. EA not only increases children's risks, such as drains and dehiscence, but also increases caregiver stress and reduces parental satisfaction with the method of anesthesia.
This trial is a randomized single-blind clinical trial. The padiatric patients were randomly divided into 4 groups.The block randomization is generated by statistical professionals using SAS9.2 software. The block size is fixed at 8 and randomly changed. Each random number and the corresponding assignment result are placed in a sealed in a transparent envelope. The investigator is responsible for including subjects according to the requirements of the program. When the subjects meet the inclusion criteria but not the exclusion criteria, the field staff will open the envelopes in order to group them.The clinical anesthesia and data statistical analysis were completed by different anesthesiologists and participants.
The four groups of children were fasted for 6 hours and 2 hours before operation, and no preoperative medication was given. After the children were awake and entered the room, the heart rate (HR), non-invasive blood pressure (NIBP), pulse oxygen saturation (SpO2), respiratory rate (RR) and end-tidal carbon dioxide partial pressure (PetCO2) were continuously monitored. Both groups were given routine standard anesthesia induction: intravenous injection of midazolam at 0.05-0.1 mg/kg of predicted body weight (PBW), propofol at 2-4 mg/kg of PBW, and remifentanil at 1-2 ug/kg of PBW, rocuronium at 0.5-1mg/kg of PBW.After adequate pre-oxygenation,laryngeal mask was placed.Anesthesia was maintained by inhalation of 2%-3% sevoflurane and continuous pumping of remifentanil at 0.2-0.4ug/kg/min remifentanil, with an oxygen flow of 2L/min. The tidal volume method was used in all mechanical ventilation. The tidal volume was between 6 and 8 mL/kg, the respiratory rate was between 18 and 24 breaths/min, and the PetCO2 was maintained between 30 and 35 mmHg. Three minutes before the end of surgery, the oxygen flow was adjusted to 6 L/min, sevoflurane was stopped, and the infusion of remifentanil was stopped. At the end of the operation, the children in all groups received local infiltration anesthesia with 0.3% ropivacaine around the incision by the surgeon.
The children in group A were given 1 mg/kg propofol intravenous bolus 3 minutes before the end of the operation.Children in group B were given continuous pumping of 1 mg/kg propofol 3 minutes before the end of the operation, and the infusion time was 3 minutes. Children in group C 1 mg/kg propofol was given intravenously at the end of the operation. Children in group D were not given propofol and served as a blank control group.
All data were collected, aggregated and maintained by a single investigator.The primary outcome measure was the anesthesia emergence delirium scale (PAED). The observation was performed during the recovery period of the child, and the child opened his eyes voluntarily to the stage of complete recovery of consciousness. Mainly from the three aspects of eye contact, behavior and consciousness, the total score is 20 points. 15 points for severe agitation.In addition, the indicators we collected also include age, gender, weight, ASA classification, operation method, operation time, discharge time and occurrence of adverse reactions and so on.
The full analysis set was used for analysis. According to the basic principle of Intention-to-Treat (ITT), the analysis of the main indicators includes all randomized subjects, regardless of whether they completed the trial or not, that is, subjects who were lost to follow-up should also be included in the statistical analysis. Statistical software SPSS 26.0 was used for data processing and statistical analysis. Shapiro-Wilk test was first performed on the data, and continuous variable data (such as blood pressure, heart rate, driving pressure, oxygenation index, etc.) were determined to use Analysis of variance or Kruskal-Wallis H test according to their normal distribution. Categorical variables (such as age,incidence of EA, etc.) were tested by χ² test, Fisher's exact test, and the results were expressed as mean ± standard deviation (SD), percentage (%) or median (interquartile range, IQR), P <0.05 is statistically significant.
- Conditions
- Anesthesia, Surgery
- Being tested
- Propofol bolus, Propofol continuous infusion
- Keywords
- Emergence Agitation, Ambulatory Surgery, Preschool Children, Propofol
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol bolusDrug
Also called 3 minutes before the end of the surgery
A bolus dose of propofol 1 mg/kg was administered intravenously at 3 minutes before the end of the surgery.
Propofol continuous infusionDrug
Also called 3 min intravenous pumping
1 mg/kg propofol was started by continuous infusion 3 minutes before the end of surgery, and the infusion time was 3 minutes.
Propofol bolusDrug
Also called at the end of the surgery
A bolus dose of propofol 1 mg/kg was administered intravenously at the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Bolus group A | Active comparator | 42 participants will receive 1 mg/kg intravenous bolus of propofol 3 min before the end of surgery. Receives: Drug: Propofol bolus |
| Continuous infusion group | Active comparator | 42 participants will receive 1 mg/kg continuous intravenous pumping of propofol 3 minutes before the end of the operation, and the pumping time was 3 minutes. Receives: Drug: Propofol continuous infusion |
| Bolus group B | Active comparator | 42 participants will receive 1 mg/kg intravenous bolus of propofol at the end of surgery. Receives: Drug: Propofol bolus |
| Blank Comparator group | No intervention | 42 participants will not receive propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of emergence agitation
Pediatric anesthesia emergence delirium scale (PAED). The total score is 20 points.A score of 10 or above is considered as EA and 15 or above is considered as severe EA.
Measured: Within up to 30 minutes after operation
Secondary outcomes (2)
length of hospital stay
The length of time the patient took from leaving the operating room to being discharged from the hospital.
Measured: 1 day post surgery
The occurrence of adverse reactions
These include both gastrointestinal and respiratory reactions
Measured: Within up to 30 minutes after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Aug 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiaxiang Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiaxiang Chen, Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420402
- Sponsor's protocol ID
- SZanes0712
- Status last verified
- Oct 2022
- First submitted
- 1 Jun 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Fabricant PD, Seeley MA, Rozell JC, Fieldston E, Flynn JM, Wells LM, Ganley TJ. Cost Savings From Utilization of an Ambulatory Surgery Center for Orthopaedic Day Surgery. J Am Acad Orthop Surg. 2016 Dec;24(12):865-871. doi: 10.5435/JAAOS-D-15-00751.
PubMed 27792057Shinnick JK, Short HL, Heiss KF, Santore MT, Blakely ML, Raval MV. Enhancing recovery in pediatric surgery: a review of the literature. J Surg Res. 2016 May 1;202(1):165-76. doi: 10.1016/j.jss.2015.12.051. Epub 2016 Jan 12.
PubMed 27083963Moore AD, Anghelescu DL. Emergence Delirium in Pediatric Anesthesia. Paediatr Drugs. 2017 Feb;19(1):11-20. doi: 10.1007/s40272-016-0201-5.
PubMed 27798810Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016 Apr;30(2):261-7. doi: 10.1007/s00540-015-2098-5. Epub 2015 Nov 24.
PubMed 26601849Jacob Z, Li H, Makaryus R, Zhang S, Reinsel R, Lee H, Feng T, Rothman DL, Benveniste H. Metabolomic profiling of children's brains undergoing general anesthesia with sevoflurane and propofol. Anesthesiology. 2012 Nov;117(5):1062-71. doi: 10.1097/ALN.0b013e31826be417.
PubMed 22929729Chidambaran V, Costandi A, D'Mello A. Propofol: a review of its role in pediatric anesthesia and sedation. CNS Drugs. 2015 Jul;29(7):543-63. doi: 10.1007/s40263-015-0259-6.
PubMed 26290263Wu X, Cao J, Shan C, Peng B, Zhang R, Cao J, Zhang F. Efficacy and safety of propofol in preventing emergence agitation after sevoflurane anesthesia for children. Exp Ther Med. 2019 Apr;17(4):3136-3140. doi: 10.3892/etm.2019.7289. Epub 2019 Feb 20.
PubMed 30930979van Hoff SL, O'Neill ES, Cohen LC, Collins BA. Does a prophylactic dose of propofol reduce emergence agitation in children receiving anesthesia? A systematic review and meta-analysis. Paediatr Anaesth. 2015 Jul;25(7):668-76. doi: 10.1111/pan.12669. Epub 2015 Apr 27.
PubMed 25917689Malarbi S, Stargatt R, Howard K, Davidson A. Characterizing the behavior of children emerging with delirium from general anesthesia. Paediatr Anaesth. 2011 Sep;21(9):942-50. doi: 10.1111/j.1460-9592.2011.03646.x. Epub 2011 Jul 5.
PubMed 21726352Bajwa SA, Costi D, Cyna AM. A comparison of emergence delirium scales following general anesthesia in children. Paediatr Anaesth. 2010 Aug;20(8):704-11. doi: 10.1111/j.1460-9592.2010.03328.x.
PubMed 20497353Chen J, Shi X, Hu W, Lin R, Meng L, Liang C, Ma X, Xu L. Comparing different administration methods of subanaesthetic propofol to mitigate emergence agitation in preschool children undergoing day surgery: a double-blind, randomised controlled study. BMJ Paediatr Open. 2025 Mar 15;9(1):e002376. doi: 10.1136/bmjpo-2023-002376.
PubMed 40090678
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Administrations of Propofol on Emergence Agitation in Preschool Children Undergoing Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT05420402
- Acronym / sponsor ID
- SZanes0712
- Conditions
- Anesthesia, Surgery
- Keywords
- Emergence Agitation, Ambulatory Surgery, Preschool Children, Propofol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Jiaxiang ChenUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 15 Jun 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.
This study evaluates the influence of different dose and methods of propofol on emergence agitation(EA) through a randomized controlled trial when preschool children undergoing ambulatory surgery of inguinal hernia.
Detailed description
Emergency agitation (EA) is the manifestation of excitement, high irritability, intense struggle, and increased blood pressure and heart rate during the recovery period of general anesthesia. It is a common adverse reaction after general anesthesia. The incidence in preschool children is 10%-80%, which is currently considered to be mainly related to factors such as the use of inhalation anesthetics, pain stimulation, drug types, surgical methods, and environmental changes. EA not only increases children's risks, such as drains and dehiscence, but also increases caregiver stress and reduces parental satisfaction with the method of anesthesia.
This trial is a randomized single-blind clinical trial. The padiatric patients were randomly divided into 4 groups.The block randomization is generated by statistical professionals using SAS9.2 software. The block size is fixed at 8 and randomly changed. Each random number and the corresponding assignment result are placed in a sealed in a transparent envelope. The investigator is responsible for including subjects according to the requirements of the program. When the subjects meet the inclusion criteria but not the exclusion criteria, the field staff will open the envelopes in order to group them.The clinical anesthesia and data statistical analysis were completed by different anesthesiologists and participants.
The four groups of children were fasted for 6 hours and 2 hours before operation, and no preoperative medication was given. After the children were awake and entered the room, the heart rate (HR), non-invasive blood pressure (NIBP), pulse oxygen saturation (SpO2), respiratory rate (RR) and end-tidal carbon dioxide partial pressure (PetCO2) were continuously monitored. Both groups were given routine standard anesthesia induction: intravenous injection of midazolam at 0.05-0.1 mg/kg of predicted body weight (PBW), propofol at 2-4 mg/kg of PBW, and remifentanil at 1-2 ug/kg of PBW, rocuronium at 0.5-1mg/kg of PBW.After adequate pre-oxygenation,laryngeal mask was placed.Anesthesia was maintained by inhalation of 2%-3% sevoflurane and continuous pumping of remifentanil at 0.2-0.4ug/kg/min remifentanil, with an oxygen flow of 2L/min. The tidal volume method was used in all mechanical ventilation. The tidal volume was between 6 and 8 mL/kg, the respiratory rate was between 18 and 24 breaths/min, and the PetCO2 was maintained between 30 and 35 mmHg. Three minutes before the end of surgery, the oxygen flow was adjusted to 6 L/min, sevoflurane was stopped, and the infusion of remifentanil was stopped. At the end of the operation, the children in all groups received local infiltration anesthesia with 0.3% ropivacaine around the incision by the surgeon.
The children in group A were given 1 mg/kg propofol intravenous bolus 3 minutes before the end of the operation.Children in group B were given continuous pumping of 1 mg/kg propofol 3 minutes before the end of the operation, and the infusion time was 3 minutes. Children in group C 1 mg/kg propofol was given intravenously at the end of the operation. Children in group D were not given propofol and served as a blank control group.
All data were collected, aggregated and maintained by a single investigator.The primary outcome measure was the anesthesia emergence delirium scale (PAED). The observation was performed during the recovery period of the child, and the child opened his eyes voluntarily to the stage of complete recovery of consciousness. Mainly from the three aspects of eye contact, behavior and consciousness, the total score is 20 points. 15 points for severe agitation.In addition, the indicators we collected also include age, gender, weight, ASA classification, operation method, operation time, discharge time and occurrence of adverse reactions and so on.
The full analysis set was used for analysis. According to the basic principle of Intention-to-Treat (ITT), the analysis of the main indicators includes all randomized subjects, regardless of whether they completed the trial or not, that is, subjects who were lost to follow-up should also be included in the statistical analysis. Statistical software SPSS 26.0 was used for data processing and statistical analysis. Shapiro-Wilk test was first performed on the data, and continuous variable data (such as blood pressure, heart rate, driving pressure, oxygenation index, etc.) were determined to use Analysis of variance or Kruskal-Wallis H test according to their normal distribution. Categorical variables (such as age,incidence of EA, etc.) were tested by χ² test, Fisher's exact test, and the results were expressed as mean ± standard deviation (SD), percentage (%) or median (interquartile range, IQR), P <0.05 is statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bolus group A | Active comparator | Drug: Propofol bolus42 participants will receive 1 mg/kg intravenous bolus of propofol 3 min before the end of surgery. |
| Continuous infusion group | Active comparator | Drug: Propofol continuous infusion42 participants will receive 1 mg/kg continuous intravenous pumping of propofol 3 minutes before the end of the operation, and the pumping time was 3 minutes. |
| Bolus group B | Active comparator | Drug: Propofol bolus42 participants will receive 1 mg/kg intravenous bolus of propofol at the end of surgery. |
| Blank Comparator group | No intervention | –42 participants will not receive propofol |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 2-5 years
- ASA classification 1
- Written informed consent
- Children undergoing ambulatory surgery of inguinal hernia
- The operation will take no more than 20 minutes
Key exclusion criteria (4 listed)
- Allergic to drugs used in the study
- Neurological disorders
- Congenital heart insufficiency
- Recent respiratory illness
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 |
|---|---|---|
| Propofol bolusAlso: 3 minutes before the end of the surgeryA bolus dose of propofol 1 mg/kg was administered intravenously at 3 minutes before the end of the surgery. | Drug | Bolus group A |
| Propofol continuous infusionAlso: 3 min intravenous pumping1 mg/kg propofol was started by continuous infusion 3 minutes before the end of surgery, and the infusion time was 3 minutes. | Drug | Continuous infusion group |
| Propofol bolusAlso: at the end of the surgeryA bolus dose of propofol 1 mg/kg was administered intravenously at the end of the surgery. | Drug | Bolus group B |
Primary outcome
The incidence of emergence agitation
Time frame: Within up to 30 minutes after operation
Pediatric anesthesia emergence delirium scale (PAED). The total score is 20 points.A score of 10 or above is considered as EA and 15 or above is considered as severe EA.
2 secondary outcomes
length of hospital stay
Time frame: 1 day post surgery
The occurrence of adverse reactions
Time frame: Within up to 30 minutes after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Results publication: PubMed 27792057Fabricant PD, Seeley MA, Rozell JC, Fieldston E, Flynn JM, Wells LM, Ganley TJ. Cost Savings From Utilization of an Ambulatory Surgery Center for Orthopaedic Day Surgery. J Am Acad Orthop Surg. 2016 Dec;24(12):865-871. doi: 10.5435/JAAOS-D-15-00751.
- Results publication: PubMed 27083963Shinnick JK, Short HL, Heiss KF, Santore MT, Blakely ML, Raval MV. Enhancing recovery in pediatric surgery: a review of the literature. J Surg Res. 2016 May 1;202(1):165-76. doi: 10.1016/j.jss.2015.12.051. Epub 2016 Jan 12.
- Results publication: PubMed 27798810Moore AD, Anghelescu DL. Emergence Delirium in Pediatric Anesthesia. Paediatr Drugs. 2017 Feb;19(1):11-20. doi: 10.1007/s40272-016-0201-5.
- Results publication: PubMed 26601849Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016 Apr;30(2):261-7. doi: 10.1007/s00540-015-2098-5. Epub 2015 Nov 24.
- Results publication: PubMed 22929729Jacob Z, Li H, Makaryus R, Zhang S, Reinsel R, Lee H, Feng T, Rothman DL, Benveniste H. Metabolomic profiling of children's brains undergoing general anesthesia with sevoflurane and propofol. Anesthesiology. 2012 Nov;117(5):1062-71. doi: 10.1097/ALN.0b013e31826be417.
- Results publication: PubMed 26290263Chidambaran V, Costandi A, D'Mello A. Propofol: a review of its role in pediatric anesthesia and sedation. CNS Drugs. 2015 Jul;29(7):543-63. doi: 10.1007/s40263-015-0259-6.
- Results publication: PubMed 30930979Wu X, Cao J, Shan C, Peng B, Zhang R, Cao J, Zhang F. Efficacy and safety of propofol in preventing emergence agitation after sevoflurane anesthesia for children. Exp Ther Med. 2019 Apr;17(4):3136-3140. doi: 10.3892/etm.2019.7289. Epub 2019 Feb 20.
- Results publication: PubMed 25917689van Hoff SL, O'Neill ES, Cohen LC, Collins BA. Does a prophylactic dose of propofol reduce emergence agitation in children receiving anesthesia? A systematic review and meta-analysis. Paediatr Anaesth. 2015 Jul;25(7):668-76. doi: 10.1111/pan.12669. Epub 2015 Apr 27.
- Results publication: PubMed 21726352Malarbi S, Stargatt R, Howard K, Davidson A. Characterizing the behavior of children emerging with delirium from general anesthesia. Paediatr Anaesth. 2011 Sep;21(9):942-50. doi: 10.1111/j.1460-9592.2011.03646.x. Epub 2011 Jul 5.
- Results publication: PubMed 20497353Bajwa SA, Costi D, Cyna AM. A comparison of emergence delirium scales following general anesthesia in children. Paediatr Anaesth. 2010 Aug;20(8):704-11. doi: 10.1111/j.1460-9592.2010.03328.x.
- Derived from this study: PubMed 40090678Chen J, Shi X, Hu W, Lin R, Meng L, Liang C, Ma X, Xu L. Comparing different administration methods of subanaesthetic propofol to mitigate emergence agitation in preschool children undergoing day surgery: a double-blind, randomised controlled study. BMJ Paediatr Open. 2025 Mar 15;9(1):e002376. doi: 10.1136/bmjpo-2023-002376.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol bolus and Propofol continuous infusion in people with Anesthesia and Surgery, run by Jiaxiang Chen 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 5 inclusion and 4 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 13 Apr 2023. 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?
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?
The incidence of emergence agitation (time frame: Within up to 30 minutes after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05420402, which also lists 11 linked publications.
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 13 Apr 2023.