A Phase 2 interventional study of IV nalbuphine 0.1 mg/kg with induction of anesthesia. and IV nalbuphine 0.1 mg/kg at the end of surgery. in Postoperative Complications, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 3 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-02.
Sponsored by Assiut University · Phase 2, Interventional, and Prevention
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Among 10 studies in Postoperative Complications by Assiut University — 5 open to participants now, 5 under way, none of them phase 3. Postoperative Complications · Assiut University.
Among the 10 studies in Postoperative Complications by Assiut University, this one is the only one that started in 2019, is the only one in phase 2, and was the 3rd registered.
1,335 studies on the registry are indexed under Postoperative Complications; 310 are open to participants now.
Browse Postoperative Complications studies →5 of the 10 studies in Postoperative Complications by Assiut University are open now, in 1 country. Recruiting first, the newest first:
Assiut University · Sites in Egypt
Ages 40+
Assiut University
Ages 18–40
Assiut University
Ages 18+
Assiut University
Ages 18+
Assiut University · Sites in Egypt
Ages 1 days–18 yrs
By country, each count listing its studies:
Of the 201 Postoperative Complications studies recruiting now, 125 (62%) set no upper age limit and 32 (16%) stop at 75 or younger; 25 take children under 18; 25 take healthy volunteers.
This study: 3 Years to 8 Years · all sexes · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 1 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 80 is below the median of 115 across 768 interventional studies indexed under Postoperative Complications.
Median enrollment 90 across the 6 interventional studies, 42 across the 4 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
5 of the studies in Postoperative Complications by Assiut University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07884006Assiut UniversityImpact of Nutritional Status Before Joint Replacement on Infection Risk | 2026-12-01 |
| NCT07547826Assiut UniversityEfficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies | 2027-05 |
| NCT07797868Assiut UniversityVacuum-Assisted Closure Versus Graduated Primary Skin Closure for Postoperative Burst Abdomen | 2027-10 |
| NCT07892586Assiut UniversityLow-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery | 2027-10-20 |
| NCT07918495Assiut UniversityEffect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy | 2027-11 |
Add all 5 to your calendar (.ics) → With an account.
Among the 10 studies in Postoperative Complications by Assiut University, from their registry updates:
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Our primary objective of this study is to compare the effect of administration of single dose of intravenous nalbuphine given with induction of anesthesia with intravenous nalbuphine given at the end of surgery on the incidence and severity of EA in children undergoing repair of rupture globe under general anesthesia.
The secondary outcomes will include FLACC score for postoperative pain assessment, hemodynamic variables, any complications as postoperative vomiting (POV) and sedation and parents' satisfaction score.
Postoperative agitation, also referred to as emergence delirium is characterized by mental confusion, irritability, disorientation, inconsolable crying, and increased recovery time in the post anesthesia recovery room, increasing parents' concern and anxiety with respect to the clinical condition of their children . It can also lead to possible injury, damage to surgical dressings, lost intravenous catheters, disconnected cables and monitoring instruments, and source of dissatisfaction for parents, nurses, and others taking care of these children, and hence the children require extra nursing care and supplemental sedative and/or analgesic medications, which may delay patient discharge from hospital and are seven times more likely to have new-onset separation anxiety, apathy, and eating and sleep problems.
It is during the first 30 minutes after emergence that the greatest incidence of agitation is observed, and duration is generally limited and recovery occurs spontaneously. However, prolonged episodes of agitation lasting for up to 2 days have been described.
There is no definitive explanation for emergence agitation (EA). Many different causes have been suggested, such as rapid return of consciousness in an unfamiliar environment, the presence of pain (wounds, sore throat, and bladder distension), stressful induction, airway obstruction, a noisy environment, the duration of anesthesia, the child's personality, anesthetic premedication and the anesthetic technique used.
While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of EA in both adults and children . Children undergoing strabismus surgery under sevoflurane anesthesia often experience EA and postoperative vomiting (POV) .
Multiple medications including ketamine, propofol, clonidine, midazolam and fentanyl have been used effectively to prevent EA. However, these medications may increase sedation after anesthesia, cause slow awakening, and in some cases are associated with undesirable side effects, such as nausea and vomiting.
Nalbuphine is a synthetic opioid κ-receptor agonist μ-receptor antagonist with onset of action occurring within 2-3 min following IV injection, duration of analgesia of 3-6 hours and plasma half-life of 5 hours. Its analgesic potency approximately equals to morphine with less effects on cardiovascular and respiratory system, i.e., nalbuphine causes less intensive and less frequent decrease in blood pressure and respiratory depression.
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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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
40 randomly allocated Patients undergoing repair of rupture globe will receive IV nalbuphine 0.1 mg/kg with induction of anesthesia.
Drug: IV nalbuphine 0.1 mg/kg with induction of anesthesia.
40 randomly allocated Patients undergoing repair of rupture globe.will receive IV nalbuphine 0.1 mg/kg at the end of surgery just before discontinuation of anesthesia.
Drug: IV nalbuphine 0.1 mg/kg at the end of surgery.
Drug page: Nalbuphine
Group A: 40 patients will receive IV nalbuphine 0.1 mg/kg with induction of anesthesia. .
Also known as: nalufin
Drug page: Nalbuphine
Group B: 40 patients will receive IV nalbuphine 0.1 mg/kg at the end of surgery just before discontinuation of anesthesia.
Also known as: nalufin
The incidence of Emergence Agitation in children undergoing repair of rupture globe under general anesthesia
the Incidence of Emergence Agitation will be evaluated using Aono's four-point scale. * minimum score: 1 * maximum score:4 Scores of one and two were considered as absence of EA, and scores of 3 and 4 were analyzed as presence of Emergence Agitation. 1. Calm 2. Not calm, but could be easily calmed 3. Moderately agitated or restless 4. Combative, excited, disoriente
Time frame: at the first 30 minutes after surgery
The severity of Emergency Agitation
5- The severity of EA will be evaluated using the pediatric anesthesia emergence delirium scale A perfectly calm child scores 0 and extreme agitation corresponds to 20 points Agitation scores less than 10 will be interpreted as an absence of agitation, scores ≥ 10 will be regarded as presence of agitation, and scores ≥15 will be regarded as severe agitation
Time frame: at the first 30 minutes after surgery
postoperative vomiting
Postoperative vomiting will be assessed using a numeric rank score * minimum score: 0 * maximum score: 2 higher values represent a worse outcome and lowest values represent a better outcome 0 = no vomiting, 1 = vomited once, and 2 = vomited twice or more.
Time frame: first 48 hours after surgery
Postoperative sedation
Postoperative sedation will be assessed using sedation score described by Culebras et al (2001) * minimum score: 1 * maximum score: 5 higher values represent a worse outcome and lowest values represent a better outcome 1. Awake and alert. 2. Sleeping but easily arouses to voice or light touch. 3. Arouses to loud voice or shaking. 4. Arouses with painful stimuli only. 5. Unarousable).
Time frame: first 48 hours after surgery
Postoperative FLACC Pain Score
Face, Legs, Activity, Cry, and Consolability (FLACC) pain score
Time frame: first 24 hours after surgery
Ran from Jul 2019 to primary completion in Sep 2020, 13 months.
Of 13 phase 2 interventional studies under Postoperative Complications, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nalbuphine