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Cervix NeoplasmsNCT04295109

Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function

A study of Cervix Neoplasms and Endometrial Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Postoperative ileus (POI) is a transient loss of coordinated peristalsis precipitated by surgery and exacerbated by opioid pain medication.So,how to provide patients with ideal analgesia without affecting the recovery of postoperative gastrointestinal function?This was a prospective randomized controlled study. Read more about this study

Who is it for?
Ages 40 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cervix Neoplasms, Endometrial Cancer, Adenomyosis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteChina
Study dates
2 Mar 2020to 31 Jul 2020
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 40 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • patients who were scheduled for laparoscopic hysterectomy from W\&C BRANCH HOSPITAL OF JIANGSU PROVINCE HOSPITAL
  • American Society of Anesthesiologists (ASA) physical status classification 1 to 2,
  • Women aged 40-65
  • Weight 50-80 kg

Who cannot join

  • History of opioids abuse and allergy and contraindication to opioid drugs
  • bronchial asthma; coronary heart disease; severe hypertension; diabetes mellitus;
  • hepatic, and renal dysfunction (glutamyl aminotransferase> 40U or aspartate aminotransferase> 35U; urea nitrogen> 8.2 μmol / L, creatinine> 133 μmol / L),
  • History of brain damage or psychiatric disease
  • Patients with coagulopathy (PT> 17 seconds or activated partial thromboplastin time (APTT)> 47 seconds);
  • pregnant or lactating women;
Show all 10Show fewer
  • Those with long-term constipation;
  • History of digestive diseases;
  • history of gastrointestinal disease (peptic ulcer disease, Crohn's disease, or ulcerative colitis)
  • Participants in other drug trials in the past three months. （11）After randomization and allocation, patients were withdrawn if laparoscopy was converted to open surgery or if they required reinvestigation for postoperative bleeding.

Trial locations and contacts

1 site in 1 country.

Cunming Liu, doctorate contact

13951890866

1335587409@qq.com

Minna Guo, Master contact

18835162576

1653474602@qq.com

China1 site, 1 recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Cunming Liu, 13951890866, 1335587409@qq.com

    Minna Guo, 18835162576, 1653474602@qq.com

    Recruiting

Other trials in China

About this study

Official title: Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function in Patients Undergoing Laparoscopic Hysterectomy: a Double-blind, a Randomized Controlled Trial

Postoperative ileus (POI) is a transient loss of coordinated peristalsis precipitated by surgery and exacerbated by opioid pain medication.So,how to provide patients with ideal analgesia without affecting the recovery of postoperative gastrointestinal function?This was a prospective randomized controlled study. A total of 105 patients who were scheduled for laparoscopic hysterectomy were randomly selected from The First Affiliated Hospital with Nanjing Medical University by random number table. These patients were randomly divided into three groups: fentanyl(F) group, oxycodone(O) group and butorphanol(B) group.

Read the detailed description

Background: Patients often experience pain after gynecological laparoscopy. However, the use of opioid analgesia after surgery may increase the incidence of postoperative ileus (POI). Postoperative ileus (POI) is a common surgical emergency after a surgical procedure, leading to infection and intestinal adhesions, which can extend hospitalization and increase readmission rates, and consequently increasing healthcare costs. How to provide patients with ideal analgesia without affecting the recovery of postoperative gastrointestinal function? There is no guideline which has been troubling clinical anesthesiologists.

Aims: To observe the effects of fentanyl, oxycodone, Butorphanol on the recovery of gastrointestinal function after laparoscopic hysterectomy.

Methods: A total of 105 patients undergoing laparoscopic hysterectomy were randomly divided to three groups: fentanyl group(group F), butorphanol group(group B), or oxycodone group(group O). The primary outcome measures were postoperative time to first anal exhaust the total analgesic doses in PCIA,effective bolus times. Patients were also assessed for pain with a visual analogue scale (VAS), the cumulative PCIA dose, adverse effects (Nausea,vomiting, bradycardia, respiratory depression and pruritus), sedation level at 4, 12, 24, and 48 hours postoperatively, and satisfaction during the postoperative 48 hours and postoperative hospitalization days.

Being tested
the drug of intravenous patient-controlled analgesia
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms, Adenomyosis, Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • the drug of intravenous patient-controlled analgesiaDrug

    Also called intravenous patient-controlled analgesia (IV-PCA)

    At present, opioids are most widely used in postoperative analgesia. This study aims to use different opioid receptor agonists---fentanyl, oxycodone and butorphanol for analgesia after laparoscopic hysterectomy.Compare the recovery of gastrointestinal function after operation.

Study groups in NCT04295109
Study groupRoleWhat they receive
Fentanyl group(group F)Active comparatorFentanyl citrate injection, specification: 10mL: 0.5mg / piece (production unit: niching chang rendu Pharmaceutical Co., Ltd., valid period: 48 months) For group F patients,0.5mg fentanyl was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes
Receives: Drug: the drug of intravenous patient-controlled analgesia
Oxycodone group(group O)ExperimentalOxycodone hydrochloride injection, specification: 1mL: 10mg / branch (production unit: HAMOL LIMITED, valid period: 60 months) For group O patients,30mg oxycodone was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes
Receives: Drug: the drug of intravenous patient-controlled analgesia
Butorphanol group(group B)ExperimentalButorphanol tartrate injection, specification: 1 mL: 1 mg / branch (production unit: Jiangsu henryi Pharmaceutical Co., Ltd., valid period: 24 months); For group B patients,10mg butorphanol was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes
Receives: Drug: the drug of intravenous patient-controlled analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative time to first anal exhaust

    Timing from the end of the operation

    Measured: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 15 days

  2. the cumulative dose administered in the patient-controlled mode

    The cumulative dose administered in the patient-controlled mode during the initial 48 hours after the operation was measured

    Measured: From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours

  3. effective bolus times

    The effective bolus times in the patient-controlled mode during the initial 48 hours after the operation was measured

    Measured: From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours

Secondary outcomes (14)

  1. pain score

    by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)

    Measured: at 4 hours postoperatively

  2. pain score

    by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)

    Measured: at 12 hours postoperatively

  3. pain score

    by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)

    Measured: at 24 hours postoperatively

  4. pain score

    by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)

    Measured: at 48 hours postoperatively

  5. Sedation score

    by using Ramsay scale（1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable）

    Measured: at 4 hours postoperatively

  6. Sedation score

    by using Ramsay scale（1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable）

    Measured: at 12 hours postoperatively

  7. Sedation score

    by using Ramsay scale（1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable）

    Measured: at 24 hours postoperatively

  8. Sedation score

    by using Ramsay scale（1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable）

    Measured: at 48 hours postoperatively

  9. adverse effects

    Nausea 、vomiting 、bradycardia（HR <60 beats min-1）、respiratory depression(According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa) and pruritus

    Measured: at 4 hours postoperatively

  10. adverse effects

    Nausea 、vomiting 、bradycardia（HR <60 beats min-1）、respiratory depression(According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial carbon dioxide (CO2)tension >6.66 kPa) and pruritus

    Measured: at 12 hours postoperatively

  11. adverse effects

    Nausea 、vomiting 、bradycardia（HR <60 beats min-1）、respiratory depression (According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa)and pruritus

    Measured: at 24 hours postoperatively

  12. adverse effects

    Nausea 、vomiting 、bradycardia（HR <60 beats min-1）、respiratory depression (According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa)and pruritus

    Measured: at 48 hours postoperatively

  13. patients' degree of overall satisfaction with the postoperative analgesia

    Patients were asked to evaluate their degree of overall satisfaction with the postoperative analgesia on a 11-point scale (0= very unsatisfied, 1-3= unsatisfied, 4-6 = neutral, 7-9= satisfied, or 10 = very satisfied).

    Measured: at 48 hours postoperatively

  14. postoperative hospitalization days

    All patients were cured in accordance with clinical cure standard

    Measured: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2020
  2. Study start2 Mar 2020
  3. Primary completion31 Jul 2020 (estimated)
  4. Study completion31 Jul 2020 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04295109
Sponsor's protocol ID
2019-SR-476
Status last verified
Apr 2020
First submitted
5 Jan 2020
Last updated
24 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guo M, Liu S, Gao J, Han C, Yang C, Liu C. The effects of fentanyl, oxycodone, and butorphanol on gastrointestinal function in patients undergoing laparoscopic hysterectomy: a prospective, double-blind, randomized controlled trial. BMC Anesthesiol. 2022 Feb 24;22(1):53. doi: 10.1186/s12871-022-01594-9.

    PubMed 35209847

Questions about this trial

What is this clinical trial studying?

A study of Cervix Neoplasms and Endometrial Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 4 inclusion and 10 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 24 Apr 2020. 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 Cunming Liu, doctorate (13951890866, 1335587409@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative time to first anal exhaust (time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 15 days). The study lists 3 primary outcomes in all. 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 NCT04295109, which also lists 1 linked publication.

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 24 Apr 2020.

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