Thyroid DisorderNCT07045870
Methods of Post Operative Analgesia in Patients Undergoing Thyroidectomy
A study testing group L : will receive lidocaine, group k : will receive Ketamine and group c: will recieve .9% saline in people with Thyroid Disorder, run by Sohag University at 1 site in Egypt.
Trial summary
this study aims to compare between effects of lidocaine and ketamine infusion on postoperative analgesia in patients undergoing thyroidectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Disorder
- What is being tested?
- group L : will receive lidocaine, group k : will receive Ketamine and group c: will recieve .9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jun 2025to 15 Dec 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 18 to 75 years old
- both sexes
- scheduled for thyroidectomy
Who cannot join
- toxic goiter
- (BMI) exceeding 30 kg / m2
- un controlled hypertension
- sever liver or kidney disorders
- allergy to study drugs
- hyperthyroidism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abdel Rahman H Abdel Rahman, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Amin, Professor
About this study
Official title: Effects of Perioperative Intravenous Lidocaine Infusion Versus Ketamine Infusion For Postoperative Analgesia in Patients Undergoing Thyroidectomy : A Randomized Controlled Trial
this study aims to compare between effects of lidocaine and ketamine infusion on postoperative analgesia in patients undergoing thyroidectomy.
- Conditions
- Thyroid Disorder
- Being tested
- group L : will receive lidocaine, group k : will receive Ketamine, group c: will recieve .9% saline
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group L : will receive lidocaineDrug
group L : will receive 1.5 mg/kg bolus of iv lidocaine 10 minutes before anaesthesia induction then continuous iv infusion rate 1.5 mg / kg / h
group k : will receive KetamineDrug
patients will receive .25 mg / kg bolus of iv ketamine 10 minutes before anaesthesia induction then continuous iv infusion of ketamine at .25 mg /kg /h
group c: will recieve .9% salineDrug
group c will be injected with equivalent volumes and rates of .9% saline using the same application scheme as the lidocaine and ketamine as a control group
| Study group | Role | What they receive |
|---|---|---|
| group L : will receive lidocaine | Active comparator | lidocaine Infusion will be given for Postoperative Analgesia in Patients Undergoing Thyroidectomy Receives: Drug: group L : will receive lidocaine |
| group k : will receive ketamine | Active comparator | Ketamine Infusion will be given for Postoperative Analgesia in Patients Undergoing Thyroidectomy Receives: Drug: group k : will receive Ketamine |
| group c: will receive .9% saline | Placebo comparator | .9% saline will be given for Postoperative Analgesia in Patients Undergoing Thyroidectomy Receives: Drug: group c: will recieve .9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of perioperative intravenous lidocaine and ketamine infusion for postoperative analgesia in patients undergoing thyroidectomy
postoperative pain by Numerical Rating Scale (NRS) Zero means no pain and ten means worst pain
Measured: 24 hours posftoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start11 Jun 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid DisorderStudies of the same condition, open and under way.
- More trials run by Sohag 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Nashaat, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045870
- Sponsor's protocol ID
- Soh-Med--25-6-11MS
- Status last verified
- Jul 2025
- First submitted
- 21 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ludwig B, Ludwig M, Dziekiewicz A, Mikula A, Cisek J, Biernat S, Kaliszewski K. Modern Surgical Techniques of Thyroidectomy and Advances in the Prevention and Treatment of Perioperative Complications. Cancers (Basel). 2023 May 26;15(11):2931. doi: 10.3390/cancers15112931.
PubMed 37296896Javidi S, Sadrizadeh S, Sadrizadeh A, Bonakdaran S, Jarahi L. Postoperative complications and long-term outcomes after total and subtotal thyroidectomy: a retrospective study. Sci Rep. 2025 Jan 29;15(1):3705. doi: 10.1038/s41598-024-79860-8.
PubMed 39881145Jain SN, Lamture Y, Krishna M. Enhanced Recovery After Surgery: Exploring the Advances and Strategies. Cureus. 2023 Oct 17;15(10):e47237. doi: 10.7759/cureus.47237. eCollection 2023 Oct.
PubMed 38022245
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Intravenous Lidocaine Infusion Versus Ketamine Infusion For Postoperative Analgesia in Patients Undergoing Thyroidectomy : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07045870
- Acronym / sponsor ID
- Soh-Med--25-6-11MS
- Conditions
- Thyroid Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 1 Jul 2025 (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.
this study aims to compare between effects of lidocaine and ketamine infusion on postoperative analgesia in patients undergoing thyroidectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group L : will receive lidocaine | Active comparator | Drug: group L : will receive lidocainelidocaine Infusion will be given for Postoperative Analgesia in Patients Undergoing Thyroidectomy |
| group k : will receive ketamine | Active comparator | Drug: group k : will receive KetamineKetamine Infusion will be given for Postoperative Analgesia in Patients Undergoing Thyroidectomy |
| group c: will receive .9% saline | Placebo comparator | Drug: group c: will recieve .9% saline.9% saline will be given for Postoperative Analgesia in Patients Undergoing Thyroidectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age from 18 to 75 years old
- both sexes
- scheduled for thyroidectomy
Key exclusion criteria (6 listed)
- toxic goiter
- (BMI) exceeding 30 kg / m2
- un controlled hypertension
- sever liver or kidney disorders
- allergy to study drugs
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 |
|---|---|---|
| group L : will receive lidocainegroup L : will receive 1.5 mg/kg bolus of iv lidocaine 10 minutes before anaesthesia induction then continuous iv infusion rate 1.5 mg / kg / h | Drug | group L : will receive lidocaine |
| group k : will receive Ketaminepatients will receive .25 mg / kg bolus of iv ketamine 10 minutes before anaesthesia induction then continuous iv infusion of ketamine at .25 mg /kg /h | Drug | group k : will receive ketamine |
| group c: will recieve .9% salinegroup c will be injected with equivalent volumes and rates of .9% saline using the same application scheme as the lidocaine and ketamine as a control group | Drug | group c: will receive .9% saline |
Primary outcome
the effect of perioperative intravenous lidocaine and ketamine infusion for postoperative analgesia in patients undergoing thyroidectomy
Time frame: 24 hours posftoperative
postoperative pain by Numerical Rating Scale (NRS) Zero means no pain and ten means worst pain
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 10 Jul 2025.
- Background: PubMed 37296896Ludwig B, Ludwig M, Dziekiewicz A, Mikula A, Cisek J, Biernat S, Kaliszewski K. Modern Surgical Techniques of Thyroidectomy and Advances in the Prevention and Treatment of Perioperative Complications. Cancers (Basel). 2023 May 26;15(11):2931. doi: 10.3390/cancers15112931.
- Background: PubMed 39881145Javidi S, Sadrizadeh S, Sadrizadeh A, Bonakdaran S, Jarahi L. Postoperative complications and long-term outcomes after total and subtotal thyroidectomy: a retrospective study. Sci Rep. 2025 Jan 29;15(1):3705. doi: 10.1038/s41598-024-79860-8.
- Background: PubMed 38022245Jain SN, Lamture Y, Krishna M. Enhanced Recovery After Surgery: Exploring the Advances and Strategies. Cureus. 2023 Oct 17;15(10):e47237. doi: 10.7759/cureus.47237. eCollection 2023 Oct.
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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.
Abdel Rahman H Abdel Rahman, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group L : will receive lidocaine, group k : will receive Ketamine and group c: will recieve .9% saline in people with Thyroid Disorder, run by Sohag 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 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: looking for participants now, as of the sponsor's last update on 10 Jul 2025. 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.
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 Mario N Ishak, Resident (01210609798, marionashaat63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of perioperative intravenous lidocaine and ketamine infusion for postoperative analgesia in patients undergoing thyroidectomy (time frame: 24 hours posftoperative). 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 NCT07045870, which also lists 3 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 10 Jul 2025.