Effects of Biased Opioid Agonists on Gastrointestinal Recovery After Gynecologic Laparoscopic Surgery
Effects of Biased Opioid Receptor Agonists on Postoperative Gastrointestinal Function Recovery in Patients Undergoing Gynecologic Laparoscopic Surgery
This randomized controlled clinical trial aims to evaluate the effects of different opioid analgesics on gastrointestinal recovery after gynecologic laparoscopic surgery.
Opioid medications are commonly used to manage pain after surgery, but they may cause nausea, vomiting, constipation, and delayed recovery of bowel function. Biased μ-opioid receptor agonists, such as tegileridine and oliceridine, may provide effective pain relief with fewer gastrointestinal side effects than conventional opioids.
The main question is whether biased opioid receptor agonists can shorten the time to postoperative gastrointestinal recovery compared with sufentanil, a conventional opioid analgesic.
The study plans to enroll 212 adults undergoing elective gynecologic laparoscopic surgery. Participants will be randomly assigned to one of four groups:
- Lower-dose tegileridine
- Higher-dose tegileridine
- Oliceridine
- Sufentanil
After surgery, participants will receive the assigned medication through a patient-controlled intravenous analgesia (PCIA) pump.
The primary outcome is time to gastrointestinal recovery (GI-2), defined as the time from the end of surgery until both the first bowel movement (defecation) and tolerance of solid food have occurred. The later of these two events determines the GI-2 recovery time.
Researchers will also assess the time to first passage of flatus, postoperative nausea and vomiting, gastrointestinal function scores, pain intensity, gastrointestinal ultrasound findings, analgesic requirements, and medication-related adverse events.
The findings may help determine whether biased opioid receptor agonists offer advantages over conventional opioid analgesics in supporting gastrointestinal recovery while maintaining adequate postoperative pain control.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Postoperative gastrointestinal dysfunction is a common concern following gynecologic laparoscopic surgery. Although opioid analgesics are widely used for postoperative pain management, their effects on gastrointestinal motility may contribute to delayed bowel function recovery, postoperative nausea and vomiting, and patient discomfort.
Biased μ-opioid receptor agonists have been developed to provide analgesia through preferential activation of specific opioid receptor signaling pathways. Tegileridine and oliceridine are of clinical interest because of their potential to provide effective postoperative analgesia while reducing certain opioid-associated adverse effects. However, their effects on gastrointestinal recovery following gynecologic laparoscopic surgery remain to be established.
This study is a prospective, randomized, controlled, single-center clinical trial conducted at the Second Affiliated Hospital of Hainan Medical University. A total of 212 adult patients undergoing elective gynecologic laparoscopic surgery are planned to be enrolled.
Participants will be randomly allocated to four parallel treatment groups receiving postoperative patient-controlled intravenous analgesia (PCIA) with one of the following regimens:
- Tegileridine 0.07 mg/kg
- Tegileridine 0.11 mg/kg
- Oliceridine 0.36 mg/kg
- Sufentanil 2.0 micrograms/kg
The primary outcome is time to gastrointestinal recovery (GI-2), defined as the time from the end of surgery until both the first bowel movement (defecation) and tolerance of solid food have occurred. GI-2 recovery time is determined by the later of these two events and is measured in hours.
Secondary outcomes include time to first passage of flatus, time to first bowel movement, postoperative gastrointestinal function assessed using the I-FEED score, postoperative nausea and vomiting, postoperative pain intensity assessed using the Visual Analog Scale (VAS), patient-controlled analgesia use, rescue analgesia requirements, and medication-related adverse events.
Gastrointestinal ultrasound examinations will be performed to assess postoperative gastrointestinal function, including gastric antral cross-sectional area and small bowel peristaltic activity. These measurements are intended to provide additional objective information about gastrointestinal recovery.
The study will compare postoperative gastrointestinal recovery, analgesic effectiveness, and safety outcomes across the four treatment groups. The findings may provide clinical evidence to inform the selection of postoperative opioid analgesic regimens for patients undergoing gynecologic laparoscopic surgery.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Shuangqing Wu
- Telefonnummer: 8618390551805
- E-mail: 1067382988@qq.com
Studiesteder
-
-
Hainan
-
Haikou, Hainan, Kina, 571199
- Rekruttering
- The Second Affiliated Hospital of Hainan Medical University
-
Kontakt:
- Shuangqing Wu
- Telefonnummer: 8618390551805
- E-mail: 1067382988@qq.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Female patients aged 18 to 75 years scheduled for elective gynecologic laparoscopic surgery.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Body mass index (BMI) between 18 and 30 kg/m².
- Normal preoperative liver and kidney function, with cardiopulmonary function adequate to tolerate surgery.
- Voluntary provision of written informed consent.
Exclusion Criteria:
- Inability to provide informed consent before surgery or difficulty communicating.
- Known allergy to any of the study medications.
- Severe hepatic impairment (Child-Pugh class C), severe renal impairment (creatinine clearance below 30 mL/min), or ongoing long-term dialysis.
- Severe cardiovascular or cerebrovascular disease, including myocardial infarction, cardiac arrest, decompensated heart failure, significant arrhythmias (such as second-degree or higher atrioventricular block without a pacemaker), congenital heart disease, severe valvular disease, extensive cerebral hemorrhage, or cerebral infarction; or significant respiratory disease, including a history of asthma, acute exacerbation of chronic obstructive pulmonary disease, or previous pulmonary resection.
- History of long-term opioid use before surgery or chronic pain.
- Pregnancy or breastfeeding.
- Other severe medical conditions or psychiatric disorders that make participation in the study unsuitable.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Low-Dose Tegileridine
Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with tegileridine at a prescribed dose of 0.07 mg/kg. |
Tegileridine is administered by patient-controlled intravenous analgesia (PCIA) after gynecologic laparoscopic surgery. The prescribed dose is 0.07 mg/kg in the low-dose group and 0.11 mg/kg in the high-dose group. Participants receive only their assigned dose regimen. |
|
Eksperimentel: High-Dose Tegileridine
Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with tegileridine at a prescribed dose of 0.11 mg/kg. |
Tegileridine is administered by patient-controlled intravenous analgesia (PCIA) after gynecologic laparoscopic surgery. The prescribed dose is 0.07 mg/kg in the low-dose group and 0.11 mg/kg in the high-dose group. Participants receive only their assigned dose regimen. |
|
Eksperimentel: Oliceridine
Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with oliceridine at a prescribed dose of 0.36 mg/kg. |
Oliceridine is administered by patient-controlled intravenous analgesia (PCIA) after gynecologic laparoscopic surgery at a prescribed dose of 0.36 mg/kg. |
|
Eksperimentel: Sufentanil
Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with sufentanil at a prescribed dose of 2.0 micrograms/kg. |
Sufentanil is administered by patient-controlled intravenous analgesia (PCIA) after gynecologic laparoscopic surgery at a prescribed dose of 2.0 micrograms/kg. This group serves as the active comparator. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Gastrointestinal Recovery (GI-2)
Tidsramme: From the end of surgery up to 7 days postoperatively.
|
GI-2 is defined as the time from the end of surgery until both the first bowel movement (defecation) and tolerance of solid food have occurred. The later of these two events determines the GI-2 recovery time, measured in hours. Participants who do not achieve GI-2 within 7 days will be recorded as not having reached the endpoint during the follow-up period. |
From the end of surgery up to 7 days postoperatively.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to First Passage of Flatus
Tidsramme: From the end of surgery up to 7 days postoperatively.
|
Time from the end of surgery to the first passage of flatus, measured in hours. A shorter time indicates earlier recovery of postoperative bowel function. |
From the end of surgery up to 7 days postoperatively.
|
|
Postoperative Gastrointestinal Function (I-FEED Score)
Tidsramme: At 6, 24, and 48 hours postoperatively.
|
Gastrointestinal function assessed using the I-FEED score at each scheduled postoperative assessment. The protocol describes a score ranging from 0 to 10, with higher scores indicating worse gastrointestinal function. |
At 6, 24, and 48 hours postoperatively.
|
|
Postoperative Pain Intensity (VAS Score)
Tidsramme: At 6, 24, and 48 hours postoperatively.
|
Postoperative pain intensity assessed using a 0-to-10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores are recorded at each scheduled assessment. |
At 6, 24, and 48 hours postoperatively.
|
|
Incidence of Postoperative Nausea and Vomiting
Tidsramme: Within 48 hours postoperatively.
|
Percentage of participants experiencing at least one episode of nausea or vomiting within 48 hours after surgery. |
Within 48 hours postoperatively.
|
|
Small Bowel Peristaltic Frequency
Tidsramme: At 6, 24, and 48 hours postoperatively.
|
Frequency of small bowel peristaltic movements assessed by ultrasonography, expressed as contractions per minute. |
At 6, 24, and 48 hours postoperatively.
|
|
Incidence of Opioid-Related Adverse Reactions
Tidsramme: Within 48 hours postoperatively.
|
Percentage of participants experiencing at least one opioid-related adverse reaction, including dizziness, somnolence, respiratory depression, pruritus, abdominal distension, or constipation, within 48 hours after surgery. |
Within 48 hours postoperatively.
|
|
Number of Patient-Controlled Analgesia Button Presses
Tidsramme: Within 48 hours postoperatively.
|
Total number of patient-initiated button presses recorded by the patient-controlled intravenous analgesia pump during the first 48 hours after surgery. |
Within 48 hours postoperatively.
|
|
Number of Rescue Analgesia Administrations
Tidsramme: Within 48 hours postoperatively.
|
Total number of rescue analgesic administrations received by each participant within 48 hours after surgery. |
Within 48 hours postoperatively.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-K51-01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .