Post Operative RecoveryNCT07739641
A COMPARATIVE STUDY BETWEEN OPIOID-FREE GENERAL ANAESTHESIA AND OPIOID-BASED GENERAL ANAESTHESIA ON THE QUALITY OF RECOVERY IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC HYSTRECTOMY: A Randomized Trial
A study testing Fentanyl-Based Anesthesia and Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine) in people with Post Operative Recovery and Post Operative Nausea and Vomiting (PONV), run by Ain Shams University at 1 site in Egypt.
Trial summary
the intent of this study To compare the efficacy of opioid free general anaesthesia versus opioid based general anaesthesia to achieve enhanced recovery regarding post-operative pain and post-operative nausea and vomiting episodes in patients undergoing elective laparoscopic hysterectomy Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Post Operative Recovery, Post Operative Nausea and Vomiting (PONV), Post Operative Analgesia
- What is being tested?
- Fentanyl-Based Anesthesia and Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Aug 2026to 20 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing a scheduled laparoscopic hysterectomy surgery under general anaesthesia.
- Age group: 40-65 years old.
- BMI<35.
- ASA I-II.
Who cannot join
- Emergency hysterectomy.
- Allergy to any of the drugs used in the study.
- HR < 50 bpm (chronic treatment by beta blockers, heart block patients).
- Alcohol or drug abuse.
- Psychiatric disease.
- Liver impairment. Kidney impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
the intent of this study To compare the efficacy of opioid free general anaesthesia versus opioid based general anaesthesia to achieve enhanced recovery regarding post-operative pain and post-operative nausea and vomiting episodes in patients undergoing elective laparoscopic hysterectomy
Read the detailed description
This prospective randomised controlled study aims to evaluate the effects of opioid-free anaesthesia (OFA) compared with conventional opioid-based anaesthesia (OBA) in adult patients undergoing elective surgery under general anaesthesia. Eligible patients will be randomly assigned into two equal groups. The OFA group will receive a multi modal opioid-free anaesthetic regimen consisting of dexmedetomidine, ketamine, and lidocaine administered as loading doses followed by continuous infusions. The OBA group will receive fentanyl-based anaesthesia according to a standardised protocol. Both groups will receive similar induction agents, muscle relaxants, anti emetic prophylaxis, and postoperative analgesic regimens.
Preoperative hemodynamic parameters, including heart rate and blood pressure, will be recorded intraoperatively and during the postoperative period. Postoperative recovery will be assessed using the SAMPE recovery room discharge checklist(Stability, Awake and Oriented, Motor, Pain, and Emesis) recovery room discharge checklist, an eight-item score assessing vital signs stability, level of consciousness, spontaneous ventilation, oxygen saturation, pain control, absence of nausea and vomiting, absence of bleeding, and absence of motor block. Patients will be discharged from the post-anaesthesia care unit (PACU) upon achieving a SAMPE score of 8.. Pain intensity will be evaluated using the Visual Analogue Scale (VAS) at predetermined postoperative time points (0, 1, 6, and 12 hours). The incidence and severity of postoperative nausea and vomiting (PONV) during the first 24 postoperative hours will be recorded and graded using a standardised PONV severity score. Additional outcomes include time to first rescue analgesia, total postoperative opioid consumption, and the occurrence of opioid-related adverse events such as postoperative hypoxemia.
Furthermore, serum interleukin-6 (IL-6) levels will be measured preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia as a biomarker of the surgical stress response. The study seeks to determine whether opioid-free anaesthesia can improve postoperative recovery, reduce PONV and opioid requirements, and attenuate the preoperative stress response compared with conventional opioid-based anaesthesia.
- Conditions
- Post Operative Recovery, Post Operative Nausea and Vomiting (PONV), Post Operative Analgesia
- Being tested
- Fentanyl-Based Anesthesia, Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine)
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl-Based AnesthesiaDrug
Fentanyl will be administered intravenously as the opioid component of balanced general anaesthesia.
Loading dose of 2 mic/kg I.V. followed by continuous infusion of three syringes, one with fentanyl infusion 0.5mic/kg/hr, and two syringes with normal saline.
will receive IV acetaminophen (1 g) and ketrolac 30mg 10 minutes before incision closure.
Postoperative Analgesia: All patients will receive IV acetaminophen 1 g /8h, ketrolac 30 mg/8h and rescue doses of pethideine 0.5 mg/kg IM if VAS score is ≥ 4.
Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine)Drug
Dexmedetomidine: Loading dose of 1 µg/kg IV over 10 min before induction, followed by continuous infusion at 0.4 µg/kg/h .
Ketamine: Loading dose of 0.25mg/kg followed by continuous infusion of ketamine at 0.1mg/kg/hr .
Lidocaine: loading dose of 1.5mg/kg/hr followed by maintainance of 1mg/kg/hr. All three infusions to be stopped 30 minutes before skin closure will receive IV acetaminophen (1 g) and ketrolac 30mg 10 minutes before incision closure.
Postoperative Analgesia: All patients will receive IV acetaminophen 1 g /8h, ketrolac 30 mg/8h and rescue doses of pethideine 0.5 mg/kg IM if VAS score is ≥ 4.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Based Anaesthesia (OBA) | Active comparator | Participants will receive conventional fentanyl-based anaesthesia during surgery in addition to standardized general anaesthesia. Receives: Drug: Fentanyl-Based Anesthesia |
| Opioid-Free Anaesthesia (OFA) Group | Active comparator | Participants will receive opioid-free anaesthesia consisting of dexmedetomidine, ketamine, and lidocaine administered as loading doses followed by continuous intravenous infusions during surgery, in addition to standardized general anaesthesia. Receives: Drug: Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Postoperative Nausea and Vomiting (PONV)
Assessment of the incidence and severity of postoperative nausea and vomiting using a standardized PONV severity score.
Measured: Within the first 24 hours postoperative.
Secondary outcomes (7)
Postoperative Pain Score
Assessment of postoperative pain using the Visual Analogue Scale (VAS). minimum better score 0 maximum worse score 10.
Measured: At 0, 1, 6, and 12 hours postoperative.
Time to First Rescue Analgesia
Time elapsed from the end of surgery until the patient requires the first rescue analgesic.
Measured: Within the first 24 hours postoperative.
Total Postoperative Opioid Consumption
Total amount of rescue opioid analgesics administered after surgery.
Measured: Within the first 24 hours postoperative .
Post-Anaesthesia Recovery Score SAMPE(score of ambulatory patients in the recovery room )
Assessment of recovery using the SAMPE(score of ambulatory patients in the recovery room ) discharge checklist evaluating vital signs stability, level of consciousness, spontaneous ventilation, oxygen saturation, pain control, absence of nausea and vomiting, absence of bleeding, and absence of motor block minimum worse score 0 maximum better score 8 .
Measured: perioperative
Prioperative Hemodynamic Parameters
Assessment of heart rate changes during and after surgery.
Measured: Intraoperatively and during the immediate postoperative period.
Serum Interleukin-6 (IL-6) Levels
Measurement of serum IL-6 concentration as a biomarker of the perioperative stress response.
Measured: Preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia.
Opioid-Related Adverse Events
Incidence of opioid-related complications, including postoperative hypoxemia.
Measured: Within the first 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start22 Aug 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative RecoveryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yomna Emad Youssef, Principal investigator, Ainshams University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739641
- Sponsor's protocol ID
- FMASU MD320/2025
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A COMPARATIVE STUDY BETWEEN OPIOID-FREE GENERAL ANAESTHESIA AND OPIOID-BASED GENERAL ANAESTHESIA ON THE QUALITY OF RECOVERY IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC HYSTRECTOMY: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07739641
- Acronym / sponsor ID
- FMASU MD320/2025
- Conditions
- Post Operative Recovery, Post Operative Nausea and Vomiting (PONV), Post Operative Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Aug 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 31 Jul 2026 (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.
the intent of this study To compare the efficacy of opioid free general anaesthesia versus opioid based general anaesthesia to achieve enhanced recovery regarding post-operative pain and post-operative nausea and vomiting episodes in patients undergoing elective laparoscopic hysterectomy
Detailed description
This prospective randomised controlled study aims to evaluate the effects of opioid-free anaesthesia (OFA) compared with conventional opioid-based anaesthesia (OBA) in adult patients undergoing elective surgery under general anaesthesia. Eligible patients will be randomly assigned into two equal groups. The OFA group will receive a multi modal opioid-free anaesthetic regimen consisting of dexmedetomidine, ketamine, and lidocaine administered as loading doses followed by continuous infusions. The OBA group will receive fentanyl-based anaesthesia according to a standardised protocol. Both groups will receive similar induction agents, muscle relaxants, anti emetic prophylaxis, and postoperative analgesic regimens.
Preoperative hemodynamic parameters, including heart rate and blood pressure, will be recorded intraoperatively and during the postoperative period. Postoperative recovery will be assessed using the SAMPE recovery room discharge checklist(Stability, Awake and Oriented, Motor, Pain, and Emesis) recovery room discharge checklist, an eight-item score assessing vital signs stability, level of consciousness, spontaneous ventilation, oxygen saturation, pain control, absence of nausea and vomiting, absence of bleeding, and absence of motor block. Patients will be discharged from the post-anaesthesia care unit (PACU) upon achieving a SAMPE score of 8.. Pain intensity will be evaluated using the Visual Analogue Scale (VAS) at predetermined postoperative time points (0, 1, 6, and 12 hours). The incidence and severity of postoperative nausea and vomiting (PONV) during the first 24 postoperative hours will be recorded and graded using a standardised PONV severity score. Additional outcomes include time to first rescue analgesia, total postoperative opioid consumption, and the occurrence of opioid-related adverse events such as postoperative hypoxemia.
Furthermore, serum interleukin-6 (IL-6) levels will be measured preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia as a biomarker of the surgical stress response. The study seeks to determine whether opioid-free anaesthesia can improve postoperative recovery, reduce PONV and opioid requirements, and attenuate the preoperative stress response compared with conventional opioid-based anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-Based Anaesthesia (OBA) | Active comparator | Drug: Fentanyl-Based AnesthesiaParticipants will receive conventional fentanyl-based anaesthesia during surgery in addition to standardized general anaesthesia. |
| Opioid-Free Anaesthesia (OFA) Group | Active comparator | Drug: Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine)Participants will receive opioid-free anaesthesia consisting of dexmedetomidine, ketamine, and lidocaine administered as loading doses followed by continuous intravenous infusions during surgery, in addition to standardized general anaesthesia. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing a scheduled laparoscopic hysterectomy surgery under general anaesthesia.
- Age group: 40-65 years old.
- BMI<35.
- ASA I-II.
Key exclusion criteria (6 listed)
- Emergency hysterectomy.
- Allergy to any of the drugs used in the study.
- HR < 50 bpm (chronic treatment by beta blockers, heart block patients).
- Alcohol or drug abuse.
- Psychiatric disease.
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 |
|---|---|---|
| Fentanyl-Based AnesthesiaFentanyl will be administered intravenously as the opioid component of balanced general anaesthesia. Loading dose of 2 mic/kg I.V. followed by continuous infusion of three syringes, one with fentanyl infusion 0.5mic/kg/hr, and two syringes with normal saline. will receive IV acetaminophen (1 g) and ketrolac 30mg 10 minutes before incision closure. Postoperative Analgesia: All patients will receive IV acetaminophen 1 g /8h, ketrolac 30 mg/8h and rescue doses of pethideine 0.5 mg/kg IM if VAS score is ≥ 4. | Drug | Opioid-Based Anaesthesia (OBA) |
| Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine)Dexmedetomidine: Loading dose of 1 µg/kg IV over 10 min before induction, followed by continuous infusion at 0.4 µg/kg/h . Ketamine: Loading dose of 0.25mg/kg followed by continuous infusion of ketamine at 0.1mg/kg/hr . Lidocaine: loading dose of 1.5mg/kg/hr followed by maintainance of 1mg/kg/hr. All three infusions to be stopped 30 minutes before skin closure will receive IV acetaminophen (1 g) and ketrolac 30mg 10 minutes before incision closure. Postoperative Analgesia: All patients will receive IV acetaminophen 1 g /8h, ketrolac 30 mg/8h and rescue doses of pethideine 0.5 mg/kg IM if VAS score is ≥ 4. | Drug | Opioid-Free Anaesthesia (OFA) Group |
Primary outcome
Incidence and Severity of Postoperative Nausea and Vomiting (PONV)
Time frame: Within the first 24 hours postoperative.
Assessment of the incidence and severity of postoperative nausea and vomiting using a standardized PONV severity score.
7 secondary outcomes
Postoperative Pain Score
Time frame: At 0, 1, 6, and 12 hours postoperative.
Time to First Rescue Analgesia
Time frame: Within the first 24 hours postoperative.
Total Postoperative Opioid Consumption
Time frame: Within the first 24 hours postoperative .
Post-Anaesthesia Recovery Score SAMPE(score of ambulatory patients in the recovery room )
Time frame: perioperative
Prioperative Hemodynamic Parameters
Time frame: Intraoperatively and during the immediate postoperative period.
Serum Interleukin-6 (IL-6) Levels
Time frame: Preoperative, immediately after skin incision, and at 6 and 12 hours after induction of anaesthesia.
Opioid-Related Adverse Events
Time frame: Within the first 24 hours postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
yomna Emad Youssef principal investigator
Ainshams University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl-Based Anesthesia and Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine) in people with Post Operative Recovery and Post Operative Nausea and Vomiting (PONV), run by Ain Shams University at 1 site in Egypt.
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 6 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: opening soon, as of the sponsor's last update on 31 Jul 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yomna emad Youssef, MBBCH (01026616629, yomnaelsayed@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Postoperative Nausea and Vomiting (PONV) (time frame: Within the first 24 hours postoperative.). 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 31 Jul 2026.