An interventional study of Fentanyl-Based Anesthesia and Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine) in Post Operative Recovery, Post Operative Nausea and Vomiting (PONV) and Post Operative Analgesia, sponsored by Ain Shams University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Among 24 studies in Vomiting with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Vomiting · Egypt.
Among the 24 studies in Vomiting with a site in Egypt, this one is the 15th largest by planned enrollment of the 23 interventional ones, is the only one that started in 2026, is one of 12 with no phase, and was the 23rd registered.
793 studies on the registry are indexed under Vomiting; 99 are open to participants now.
This study's planned enrollment of 66 is below the median of 103 across 673 interventional studies indexed under Vomiting.
Browse Vomiting studies →2 of the 24 studies in Vomiting with a site in Egypt are open now, in 1 country. Each count lists the studies.
Of the 56 Vomiting studies recruiting now, 26 (46%) set no upper age limit and 24 (43%) stop at 75 or younger; 10 take children under 18; 17 take healthy volunteers.
This study: 40 Years to 65 Years · female · no healthy volunteers.
The full table on the hub →24 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 1 started in 2026.
Median enrollment 90 across the 23 interventional studies, 75 across the 1 observational. Of the 18 that completed or were terminated, 0 (0%) have results posted.
None of the 24 has an industry lead sponsor. The 10 most frequent:
Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Ain Shams University has 5 studies filed under Vomiting — fewer than ten, so there is no comparison to draw.
1 of the studies in Vomiting with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07739641Ain Shams UniversityA 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 | 2027-02-15 |
Among the 24 studies in Vomiting with a site in Egypt, from their registry updates:
Nothing recorded among them since 2026-09-25.
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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive conventional fentanyl-based anaesthesia during surgery in addition to standardized general anaesthesia.
Drug: Fentanyl-Based Anesthesia
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.
Drug: Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, and Lidocaine)
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.
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.
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.
Time frame: Within the first 24 hours postoperative.
Postoperative Pain Score
Assessment of postoperative pain using the Visual Analogue Scale (VAS). minimum better score 0 maximum worse score 10.
Time frame: 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.
Time frame: Within the first 24 hours postoperative.
Total Postoperative Opioid Consumption
Total amount of rescue opioid analgesics administered after surgery.
Time frame: 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 .
Time frame: perioperative
Prioperative Hemodynamic Parameters
Assessment of heart rate changes during and after surgery.
Time frame: 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.
Time frame: 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.
Time frame: Within the first 24 hours postoperative.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Feb 2027, 5 months later.
Of 131 non-industry interventional studies with no phase under Vomiting, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 29. This study's planned 5 months is below that.
Counting every sponsor, half of 134 studies reached it within 13 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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