Acute PainNCT03875872
Comparison of Postoperative Outcomes Between Surgeries Anaesthetized With Propofol and Inhalational Anaesthetics
An observational study of Acute Pain, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Propofol used as anaesthesia in surgery had shown small postoperative analgesic benefits over inhalational anaesthetics in some meta-analyses. It was also associated with reduced risk of postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Propofol and inhalation anaesthetics
- How many people
- 3,922 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Feb 2019to 12 Aug 2019
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Surgical and anaesthetic data in years 2015-17 from the Acute Pain Service records of Queen Mary Hospital are included for analysis. Available data are about 6000 surgical cases. Only general anaesthesia by propofol or inhalational anaesthetics are included.
Who may be able to join
- Postoperative outcomes from Acute Pain Service data bank between Jan 2015 and Dec 2017 in Queen Mary Hospital would be retrieved;
- Surgeries with general anaesthesia by either propofol or inhalational anaesthetics.
Who cannot join
- Essential data missed;
- Surgical types with small sample size below 30 for the data collection period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Outcomes Between Surgeries Anaesthetized With Propofol and Inhalational Anaesthetics With Regression Controls for Confounders
Propofol used as anaesthesia in surgery had shown small postoperative analgesic benefits over inhalational anaesthetics in some meta-analyses. It was also associated with reduced risk of postoperative nausea and vomiting. Small sample of studies together with high heterogeneity prevented some meta-analyses to confirm propofol's effect for postoperative morphine consumption and other outcomes. Acute Pain Service data bank can provide an alternative way of evaluating postoperative outcomes of propofol anaesthetics through supplying a very large sample size in a more homogeneous setting. Retrospective study comparing propofol and inhalational anaesthetics on postoperative pain matched on patients' demographic and clinical data had been done for liver surgery. Propofol's benefits for postoperative pain and morphine consumption was confirmed but not for adverse effects.
This study plans to analyze the postoperative outcome data from an Acute Pain Service data bank in years 2015-17 to compare the anaesthetics of propofol and inhalational anaesthetics. Comprehensive regression adjustment for confounders are performed using all available patients' demographic, clinical and anaesthetic data. All major surgery types are included. Results will provide postoperative outcome differences between propofol and inhalational anaesthetics for all surgeries and for specific type of surgeries. The large sample bank will provide higher probability for detecting outcome difference between the anaesthetics for all the major surgical types.
Read the detailed description
Objective: To compare the postoperative outcomes between surgeries anaesthetized with propofol and inhalational anaesthetics in the Acute Pain Service records of Queen Mary Hospital for years 2015-17
Methods:
Retrospective
Data collection
- Demographic data;
- Type of surgery;
- Type of anaesthetic techniques;
- Postoperative NRS pain scores (Rest and Moving) for Postop Days 1, 2 \& 3;
- Accumulated amount of patient controlled analgesia (PCA) used in Postop Days 1, 2 \& 3;
- Postoperative incidence of nausea, vomitting, dizziness and pruritus.
- Conditions
- Acute Pain
- Being tested
- Propofol, inhalation anaesthetics
- Keywords
- propofol, inhalation anaesthetics, postoperative outcomes, regression control
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Patients who had surgeries and were anaesthetized with propofol at Queen Mary Hospital, Hong Kong from Jan 2015 to Dec 2017
inhalation anaestheticsDrug
Patients who had surgeries and were anaesthetized via inhalation at Queen Mary Hospital, Hong Kong from Jan 2015 to Dec 2017
| Study group | Role | What they receive |
|---|---|---|
| Group propofol | Patients who had surgeries and were anaesthetized with propofol at Queen Mary Hospital, Hong Kong from Jan 2015 to Dec 2017 Receives: Drug: Propofol | |
| Group inhalation anaesthetics | Patients who had surgeries and were anaesthetized via inhalation at Queen Mary Hospital, Hong Kong from Jan 2015 to Dec 2017 Receives: Drug: inhalation anaesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
NRS (0-10) for both rest and moving
Measured: up to postoperative day 3
Secondary outcomes (2)
analgesic consumption
amount of accumulated patient controlled analgesia (PCA) of morphine use
Measured: up to postoperative day 3
Amount of patients with adverse events in post-operation
nausea and vomit, dizziness and pruritus
Measured: up to postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start11 Feb 2019
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,922 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Sau Ching Stanley, The University of Hong Kong
- Investigators
- Stanley SC Wong, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875872
- Sponsor's protocol ID
- UW19-182
- Status last verified
- May 2023
- First submitted
- 13 Mar 2019
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qiu Q, Choi SW, Wong SS, Irwin MG, Cheung CW. Effects of intra-operative maintenance of general anaesthesia with propofol on postoperative pain outcomes - a systematic review and meta-analysis. Anaesthesia. 2016 Oct;71(10):1222-33. doi: 10.1111/anae.13578. Epub 2016 Aug 10.
PubMed 27506326Peng K, Liu HY, Wu SR, Liu H, Zhang ZC, Ji FH. Does Propofol Anesthesia Lead to Less Postoperative Pain Compared With Inhalational Anesthesia?: A Systematic Review and Meta-analysis. Anesth Analg. 2016 Oct;123(4):846-58. doi: 10.1213/ANE.0000000000001504.
PubMed 27636574Kumar G, Stendall C, Mistry R, Gurusamy K, Walker D. A comparison of total intravenous anaesthesia using propofol with sevoflurane or desflurane in ambulatory surgery: systematic review and meta-analysis. Anaesthesia. 2014 Oct;69(10):1138-50. doi: 10.1111/anae.12713. Epub 2014 May 22.
PubMed 24847783Chan AC, Qiu Q, Choi SW, Wong SS, Chan AC, Irwin MG, Cheung CW. Effects of Intra-Operative Total Intravenous Anaesthesia with Propofol versus Inhalational Anaesthesia with Sevoflurane on Post-Operative Pain in Liver Surgery: A Retrospective Case-Control Study. PLoS One. 2016 Feb 22;11(2):e0149753. doi: 10.1371/journal.pone.0149753. eCollection 2016.
PubMed 26901037Wong SSC, Choi EKY, Chan WS, Cheung CW. Propofol total intravenous anaesthesia versus inhalational anaesthesia for acute postoperative pain in patients with morphine patient-controlled analgesia: a large-scale retrospective study with covariate adjustment. BMC Anesthesiol. 2022 May 10;22(1):140. doi: 10.1186/s12871-022-01683-9.
PubMed 35538421
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Outcomes Between Surgeries Anaesthetized With Propofol and Inhalational Anaesthetics With Regression Controls for Confounders
- ClinicalTrials.gov ID
- NCT03875872
- Acronym / sponsor ID
- UW19-182
- Conditions
- Acute Pain
- Keywords
- propofol, inhalation anaesthetics, postoperative outcomes, regression control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,922 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 15 Mar 2019 (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.
Propofol used as anaesthesia in surgery had shown small postoperative analgesic benefits over inhalational anaesthetics in some meta-analyses. It was also associated with reduced risk of postoperative nausea and vomiting. Small sample of studies together with high heterogeneity prevented some meta-analyses to confirm propofol's effect for postoperative morphine consumption and other outcomes. Acute Pain Service data bank can provide an alternative way of evaluating postoperative outcomes of propofol anaesthetics through supplying a very large sample size in a more homogeneous setting. Retrospective study comparing propofol and inhalational anaesthetics on postoperative pain matched on patients' demographic and clinical data had been done for liver surgery. Propofol's benefits for postoperative pain and morphine consumption was confirmed but not for adverse effects.
This study plans to analyze the postoperative outcome data from an Acute Pain Service data bank in years 2015-17 to compare the anaesthetics of propofol and inhalational anaesthetics. Comprehensive regression adjustment for confounders are performed using all available patients' demographic, clinical and anaesthetic data. All major surgery types are included. Results will provide postoperative outcome differences between propofol and inhalational anaesthetics for all surgeries and for specific type of surgeries. The large sample bank will provide higher probability for detecting outcome difference between the anaesthetics for all the major surgical types.
Detailed description
Objective: To compare the postoperative outcomes between surgeries anaesthetized with propofol and inhalational anaesthetics in the Acute Pain Service records of Queen Mary Hospital for years 2015-17
Methods:
Retrospective
Data collection
- Demographic data;
- Type of surgery;
- Type of anaesthetic techniques;
- Postoperative NRS pain scores (Rest and Moving) for Postop Days 1, 2 \& 3;
- Accumulated amount of patient controlled analgesia (PCA) used in Postop Days 1, 2 \& 3;
- Postoperative incidence of nausea, vomitting, dizziness and pruritus.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group propofol | – | Drug: PropofolPatients who had surgeries and were anaesthetized with propofol at Queen Mary Hospital, Hong Kong from Jan 2015 to Dec 2017 |
| Group inhalation anaesthetics | – | Drug: inhalation anaestheticsPatients who had surgeries and were anaesthetized via inhalation at Queen Mary Hospital, Hong Kong from Jan 2015 to Dec 2017 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Surgical and anaesthetic data in years 2015-17 from the Acute Pain Service records of Queen Mary Hospital are included for analysis. Available data are about 6000 surgical cases. Only general anaesthesia by propofol or inhalational anaesthetics are included.
Key inclusion criteria (2 listed)
- Postoperative outcomes from Acute Pain Service data bank between Jan 2015 and Dec 2017 in Queen Mary Hospital would be retrieved;
- Surgeries with general anaesthesia by either propofol or inhalational anaesthetics.
Key exclusion criteria (2 listed)
- Essential data missed;
- Surgical types with small sample size below 30 for the data collection period.
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 |
|---|---|---|
| PropofolPatients who had surgeries and were anaesthetized with propofol at Queen Mary Hospital, Hong Kong from Jan 2015 to Dec 2017 | Drug | Group propofol |
| inhalation anaestheticsPatients who had surgeries and were anaesthetized via inhalation at Queen Mary Hospital, Hong Kong from Jan 2015 to Dec 2017 | Drug | Group inhalation anaesthetics |
Primary outcome
pain score
Time frame: up to postoperative day 3
NRS (0-10) for both rest and moving
2 secondary outcomes
analgesic consumption
Time frame: up to postoperative day 3
Amount of patients with adverse events in post-operation
Time frame: up to postoperative day 3
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 10 May 2023.
- Background: PubMed 27506326Qiu Q, Choi SW, Wong SS, Irwin MG, Cheung CW. Effects of intra-operative maintenance of general anaesthesia with propofol on postoperative pain outcomes - a systematic review and meta-analysis. Anaesthesia. 2016 Oct;71(10):1222-33. doi: 10.1111/anae.13578. Epub 2016 Aug 10.
- Background: PubMed 27636574Peng K, Liu HY, Wu SR, Liu H, Zhang ZC, Ji FH. Does Propofol Anesthesia Lead to Less Postoperative Pain Compared With Inhalational Anesthesia?: A Systematic Review and Meta-analysis. Anesth Analg. 2016 Oct;123(4):846-58. doi: 10.1213/ANE.0000000000001504.
- Background: PubMed 24847783Kumar G, Stendall C, Mistry R, Gurusamy K, Walker D. A comparison of total intravenous anaesthesia using propofol with sevoflurane or desflurane in ambulatory surgery: systematic review and meta-analysis. Anaesthesia. 2014 Oct;69(10):1138-50. doi: 10.1111/anae.12713. Epub 2014 May 22.
- Background: PubMed 26901037Chan AC, Qiu Q, Choi SW, Wong SS, Chan AC, Irwin MG, Cheung CW. Effects of Intra-Operative Total Intravenous Anaesthesia with Propofol versus Inhalational Anaesthesia with Sevoflurane on Post-Operative Pain in Liver Surgery: A Retrospective Case-Control Study. PLoS One. 2016 Feb 22;11(2):e0149753. doi: 10.1371/journal.pone.0149753. eCollection 2016.
- Derived from this study: PubMed 35538421Wong SSC, Choi EKY, Chan WS, Cheung CW. Propofol total intravenous anaesthesia versus inhalational anaesthesia for acute postoperative pain in patients with morphine patient-controlled analgesia: a large-scale retrospective study with covariate adjustment. BMC Anesthesiol. 2022 May 10;22(1):140. doi: 10.1186/s12871-022-01683-9.
- 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.
Stanley SC Wong, MBBS principal investigator
The University of Hong Kong
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 Acute Pain, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 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 10 May 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 Hong Kong. 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?
pain score (time frame: up to postoperative day 3). 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 NCT03875872, which also lists 5 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 10 May 2023.