Morbid ObesityPhase 3NCT04576975
Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery
A Phase 3 study testing Ketamine, Dexmedetomidine and Normal Saline 0.9% in people with Morbid Obesity and Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
The surgeries that involve treatment of morbid obesity, i.e. bypass procedure and sleeve gastrectomy, are collectively covered under the term 'bariatric surgery'. The frequency of bariatric surgery has been increasing worldwide for patients with medically complicated obesity who have difficulty losing weight by other… Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity, Surgery
- What is being tested?
- Ketamine, Dexmedetomidine and Normal Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2021to 1 Jul 2022
- Phase
- Phase 3
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI > 35 kg/m2
- ASA physical status II \& III (according to BMI)
- Undergoing laparoscopic bariatric surgery
Who cannot join
- Patients refusal
- ASA physical status: IV (according to BMI)
- History of hypersensitivity to dexmedetomidine and/or ketamine
- History of substance abuse (Benzodiazepines) or Chronic opioid use
- Psychiatric or Seizure disorder
- uncontrolled hypertension or heart block
- uncontrolled diabetes
- Surgical Complication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Use of Ketamine Infusion vs Dexmedetomidine Infusion as Analgesic in Obese Patients Undergoing Bariatric Surgery
The surgeries that involve treatment of morbid obesity, i.e. bypass procedure and sleeve gastrectomy, are collectively covered under the term 'bariatric surgery'. The frequency of bariatric surgery has been increasing worldwide for patients with medically complicated obesity who have difficulty losing weight by other methods
The growth of bariatric surgery is accompanied with development of anesthetic techniques to maintain patient safety and improve outcome. Treatment with narcotics in obese patients has dual effect. Increased use of narcotics are associated with multiple complications including Postoperative Nausea and Vomiting (PONV) , respiratory depression and elevated risk of Obstructive Sleep Apnea (OSA) complications . On the other hand, the reduction in opioid use may result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we need to minimize opioid use and employ some other drugs which, besides having analgesia, has an opioid-sparing effect also.
Read more
Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anesthetic doses. When used in low dose (0.3 to 0.5 mg/kg) by ideal body weight, it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance.
Dexmedetomidine is selective α2-Adrenoceptor agonist that has been used as an adjuvant to anesthetic agents in perioperative period for several adventitious profile as well as tolerated side effects . While dexmedetomidine is emerging as a beneficial adjunct to the analgesic regimen in the perioperative period, its utilization is not routinely widespread .
- Conditions
- Morbid Obesity, Surgery
- Being tested
- Ketamine, Dexmedetomidine, Normal Saline 0.9%
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use.
DexmedetomidineDrug
compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use.
Normal Saline 0.9%Drug
compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | This group will receive a bolus dose of Ketamine [Ketamine HCL - Sterop, Belgium] (0.3 mg/kg) by the ideal body weight diluted with 0.9% Normal Saline over 10 minutes by 20 ml syringe infused before induction. After which Ketamine infusion (500 mg vial diluted over 50 cc infusion syringe, concentration 10 mg/ml) will start with rate of 0.3 mg/kg/hr till 10 Minutes before the end of the surgery Receives: Drug: Ketamine |
| Dexmedetomidine | Experimental | This group will receive a bolus dose of Dexmedetomidine [Precedex® -Hospira, USA] (0.5 µcg/kg) by the ideal body weight diluted with 0.9% Normal Saline over 10 minutes by 20 ml syringe infused before induction. After which, the Dexmedetomidine infusion (200 µcg vial diluted over 50 cc infusion syringe, concentration 4 µcg/ml) will start with rate of 0.5 µcg/kg/hr till 10 Minutes before the end of the surgery Receives: Drug: Dexmedetomidine |
| Normal Saline 0.9% | Placebo comparator | This group will receive a bolus dose of NS 0.9% over 10 minutes by 20 ml syringe infused before induction. After which, NS 0.9% (50 ml over 50 cc syringe) will be infused. Receives: Drug: Normal Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy
They will be assessed for sedation score with Modified Observer's assessment of alertness/sedation scale [MOAS/S] . The score will be repeated at 10, 30 and 60 minutes.
Agitated 6 Responds readily to name spoken in normal tone (alert) 5 Lethargic response to name spoken in normal tone 4 Responds only after name is called loudly and/or repeatedly 3 Responds only after mild prodding or shaking 2 Does not respond to mild prodding or shaking 1 Does not respond to deep stimulus 0
The patient will be assessed for pain by using the Numerical Rating Scale [NRS] with score is 0 for no pain and 10 for excruciating pain. The NRS score will be recorded 30 and 60 mins and 2, 6, 12, and 24 h after the surgery.
All patients will receive paracetamol (Perfilgan ®) 1 gm IV every 6 hours for 24 hours postoperatively. A rescue dose of morphine 4 mg per needed with minimum 6 hours interval between doses if the NRS Score is ≥ 4. total doses of morphine will be calculated.
Measured: one year throughout the study
Secondary outcomes (1)
any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use
All Patients will be assessed for PONV by using PONV Intensity Scale . The score will be done 6 hours and 24 hours after the surgery. Ondansetron (Zofran®) 4 mg will be given if the patient developed intense sensation of nausea and to be repeated after 30 Minutes
All the vital data will be recorded at 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours and 24 hours from discharge of operating room.
Postoperative complication (such as; airway obstruction, development of hypoxia, serious nausea and vomiting …, etc.) will be recorded.
Measured: one year throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start20 Apr 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Kuwait
- Responsible party
- Principal investigator, Belal Nabil Mahfouz Khalil, Ain Shams University
- Investigators
- Bahaa El-Din E Ali, PhD, Study director, Ainshams University, EgyptAhmed N El-Shaer, PhD, Study director, Ainshams University, EgyptMohammad A Khaja, FCARCSI, Study director, Ministry of Health, KuwaitMohammed O Taeimah, PhD, Principal investigator, Ainshams University, EgyptMaha S Al Derh, PhD, Principal investigator, Ainshams University, EgyptBelal N Khalil, M.Sc, Principal investigator, Ainshams University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576975
- Sponsor's protocol ID
- FMASU M D 108 / 2020
- Status last verified
- Jul 2021
- First submitted
- 26 Sep 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Albaugh VL, Abumrad NN. Surgical treatment of obesity. F1000Res. 2018 May 21;7:F1000 Faculty Rev-617. doi: 10.12688/f1000research.13515.1. eCollection 2018.
PubMed 29904577Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
PubMed 21621130Ingrande J, Lemmens HJ. Dose adjustment of anaesthetics in the morbidly obese. Br J Anaesth. 2010 Dec;105 Suppl 1:i16-23. doi: 10.1093/bja/aeq312.
PubMed 21148651Liu FL, Cherng YG, Chen SY, Su YH, Huang SY, Lo PH, Lee YY, Tam KW. Postoperative recovery after anesthesia in morbidly obese patients: a systematic review and meta-analysis of randomized controlled trials. Can J Anaesth. 2015 Aug;62(8):907-17. doi: 10.1007/s12630-015-0405-0. Epub 2015 May 22.
PubMed 26001751Nonaka T, Inamori M, Miyashita T, Inoh Y, Kanoshima K, Higurashi T, Ohkubo H, Iida H, Fujita K, Kusakabe A, Gotoh T, Nakajima A. Can sedation using a combination of propofol and dexmedetomidine enhance the satisfaction of the endoscopist in endoscopic submucosal dissection? Endosc Int Open. 2018 Jan;6(1):E3-E10. doi: 10.1055/s-0043-122228. Epub 2018 Jan 12.
PubMed 29340293Vaughns JD, Martin C, Nelson J, Nadler E, Quezado ZM. Dexmedetomidine as an adjuvant for perioperative pain management in adolescents undergoing bariatric surgery: An observational cohort study. J Pediatr Surg. 2017 Nov;52(11):1787-1790. doi: 10.1016/j.jpedsurg.2017.04.007. Epub 2017 Apr 19.
PubMed 28465076Wang J, Echevarria GC, Doan L, Ekasumara N, Calvino S, Chae F, Martinez E, Robinson E, Cuff G, Franco L, Muntyan I, Kurian M, Schwack BF, Bedrosian AS, Fielding GA, Ren-Fielding CJ. Effects of a single subanaesthetic dose of ketamine on pain and mood after laparoscopic bariatric surgery: A randomised double-blind placebo controlled study. Eur J Anaesthesiol. 2019 Jan;36(1):16-24. doi: 10.1097/EJA.0000000000000860.
PubMed 30095550Wengritzky R, Mettho T, Myles PS, Burke J, Kakos A. Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010 Feb;104(2):158-66. doi: 10.1093/bja/aep370. Epub 2009 Dec 26.
PubMed 20037151Khalil BNM, Elderh MSH, Khaja MAR, El-Shaer AN, Ali BEEH, Taeimah MOA. Perioperative use of ketamine infusion versus dexmedetomidine infusion for analgesia in obese patients undergoing bariatric surgery: a double-blinded three-armed randomized controlled trial. BMC Anesthesiol. 2023 Apr 1;23(1):108. doi: 10.1186/s12871-023-02059-3.
PubMed 37005580
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Use of Ketamine Infusion vs Dexmedetomidine Infusion as Analgesic in Obese Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04576975
- Acronym / sponsor ID
- FMASU M D 108 / 2020
- Conditions
- Morbid Obesity, Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Kuwait
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 6 Oct 2020 (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 surgeries that involve treatment of morbid obesity, i.e. bypass procedure and sleeve gastrectomy, are collectively covered under the term 'bariatric surgery'. The frequency of bariatric surgery has been increasing worldwide for patients with medically complicated obesity who have difficulty losing weight by other methods
The growth of bariatric surgery is accompanied with development of anesthetic techniques to maintain patient safety and improve outcome. Treatment with narcotics in obese patients has dual effect. Increased use of narcotics are associated with multiple complications including Postoperative Nausea and Vomiting (PONV) , respiratory depression and elevated risk of Obstructive Sleep Apnea (OSA) complications . On the other hand, the reduction in opioid use may result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we need to minimize opioid use and employ some other drugs which, besides having analgesia, has an opioid-sparing effect also.
Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anesthetic doses. When used in low dose (0.3 to 0.5 mg/kg) by ideal body weight, it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance.
Dexmedetomidine is selective α2-Adrenoceptor agonist that has been used as an adjuvant to anesthetic agents in perioperative period for several adventitious profile as well as tolerated side effects . While dexmedetomidine is emerging as a beneficial adjunct to the analgesic regimen in the perioperative period, its utilization is not routinely widespread .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineThis group will receive a bolus dose of Ketamine [Ketamine HCL - Sterop, Belgium] (0.3 mg/kg) by the ideal body weight diluted with 0.9% Normal Saline over 10 minutes by 20 ml syringe infused before induction. After which Ketamine infusion (500 mg vial diluted over 50 cc infusion syringe, concentration 10 mg/ml) will start with rate of 0.3 mg/kg/hr till 10 Minutes before the end of the surgery |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineThis group will receive a bolus dose of Dexmedetomidine [Precedex® -Hospira, USA] (0.5 µcg/kg) by the ideal body weight diluted with 0.9% Normal Saline over 10 minutes by 20 ml syringe infused before induction. After which, the Dexmedetomidine infusion (200 µcg vial diluted over 50 cc infusion syringe, concentration 4 µcg/ml) will start with rate of 0.5 µcg/kg/hr till 10 Minutes before the end of the surgery |
| Normal Saline 0.9% | Placebo comparator | Drug: Normal Saline 0.9%This group will receive a bolus dose of NS 0.9% over 10 minutes by 20 ml syringe infused before induction. After which, NS 0.9% (50 ml over 50 cc syringe) will be infused. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI > 35 kg/m2
- ASA physical status II \& III (according to BMI)
- Undergoing laparoscopic bariatric surgery
Key exclusion criteria (8 listed)
- Patients refusal
- ASA physical status: IV (according to BMI)
- History of hypersensitivity to dexmedetomidine and/or ketamine
- History of substance abuse (Benzodiazepines) or Chronic opioid use
- Psychiatric or Seizure disorder
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 |
|---|---|---|
| Ketaminecompare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use. | Drug | Ketamine |
| Dexmedetomidinecompare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use. | Drug | Dexmedetomidine |
| Normal Saline 0.9%compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use. | Drug | Normal Saline 0.9% |
Primary outcome
compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy
Time frame: one year throughout the study
They will be assessed for sedation score with Modified Observer's assessment of alertness/sedation scale [MOAS/S] . The score will be repeated at 10, 30 and 60 minutes. Agitated 6 Responds readily to name spoken in normal tone (alert) 5 Lethargic response to name spoken in normal tone 4 Responds only after name is called loudly and/or repeatedly 3 Responds only after mild prodding or shaking 2 Does not respond to mild prodding or shaking 1 Does not respond to deep stimulus 0 The patient will be assessed for pain by using the Numerical Rating Scale [NRS] with score is 0 for no pain and 10 for excruciating pain. The NRS score will be recorded 30 and 60 mins and 2, 6, 12, and 24 h after the surgery. All patients will receive paracetamol (Perfilgan ®) 1 gm IV every 6 hours for 24 hours postoperatively. A rescue dose of morphine 4 mg per needed with minimum 6 hours interval between doses if the NRS Score is ≥ 4. total doses of morphine will be calculated.
1 secondary outcome
any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use
Time frame: one year throughout the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Background: PubMed 29904577Albaugh VL, Abumrad NN. Surgical treatment of obesity. F1000Res. 2018 May 21;7:F1000 Faculty Rev-617. doi: 10.12688/f1000research.13515.1. eCollection 2018.
- Background: PubMed 21621130Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
- Background: PubMed 21148651Ingrande J, Lemmens HJ. Dose adjustment of anaesthetics in the morbidly obese. Br J Anaesth. 2010 Dec;105 Suppl 1:i16-23. doi: 10.1093/bja/aeq312.
- Background: PubMed 26001751Liu FL, Cherng YG, Chen SY, Su YH, Huang SY, Lo PH, Lee YY, Tam KW. Postoperative recovery after anesthesia in morbidly obese patients: a systematic review and meta-analysis of randomized controlled trials. Can J Anaesth. 2015 Aug;62(8):907-17. doi: 10.1007/s12630-015-0405-0. Epub 2015 May 22.
- Background: PubMed 29340293Nonaka T, Inamori M, Miyashita T, Inoh Y, Kanoshima K, Higurashi T, Ohkubo H, Iida H, Fujita K, Kusakabe A, Gotoh T, Nakajima A. Can sedation using a combination of propofol and dexmedetomidine enhance the satisfaction of the endoscopist in endoscopic submucosal dissection? Endosc Int Open. 2018 Jan;6(1):E3-E10. doi: 10.1055/s-0043-122228. Epub 2018 Jan 12.
- Background: PubMed 28465076Vaughns JD, Martin C, Nelson J, Nadler E, Quezado ZM. Dexmedetomidine as an adjuvant for perioperative pain management in adolescents undergoing bariatric surgery: An observational cohort study. J Pediatr Surg. 2017 Nov;52(11):1787-1790. doi: 10.1016/j.jpedsurg.2017.04.007. Epub 2017 Apr 19.
- Background: PubMed 30095550Wang J, Echevarria GC, Doan L, Ekasumara N, Calvino S, Chae F, Martinez E, Robinson E, Cuff G, Franco L, Muntyan I, Kurian M, Schwack BF, Bedrosian AS, Fielding GA, Ren-Fielding CJ. Effects of a single subanaesthetic dose of ketamine on pain and mood after laparoscopic bariatric surgery: A randomised double-blind placebo controlled study. Eur J Anaesthesiol. 2019 Jan;36(1):16-24. doi: 10.1097/EJA.0000000000000860.
- Background: PubMed 20037151Wengritzky R, Mettho T, Myles PS, Burke J, Kakos A. Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010 Feb;104(2):158-66. doi: 10.1093/bja/aep370. Epub 2009 Dec 26.
- Derived from this study: PubMed 37005580Khalil BNM, Elderh MSH, Khaja MAR, El-Shaer AN, Ali BEEH, Taeimah MOA. Perioperative use of ketamine infusion versus dexmedetomidine infusion for analgesia in obese patients undergoing bariatric surgery: a double-blinded three-armed randomized controlled trial. BMC Anesthesiol. 2023 Apr 1;23(1):108. doi: 10.1186/s12871-023-02059-3.
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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. This study is not recruiting at the moment.
Bahaa El-Din E Ali, PhD study director
Ainshams University, Egypt
Ahmed N El-Shaer, PhD study director
Ainshams University, Egypt
Mohammad A Khaja, FCARCSI study director
Ministry of Health, Kuwait
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine, Dexmedetomidine and Normal Saline 0.9% in people with Morbid Obesity and Surgery, 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 3 inclusion and 8 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 28 Jul 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy (time frame: one year throughout the study). 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 NCT04576975, which also lists 9 linked publications.
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 28 Jul 2021.